# US 2019/0244702 A1 · Device for generating protocol data for an injection pen

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- Number: US 2019/0244702 A1
- Document ID: US20190244702A1
- Status: Published application
- Kind: A1
- Application number: 16/318,724
- Filed: 2017-07-18
- Published: 2019-08-08
- Earliest claimed: 2016-07-18
- Assignees: Roche Diabetes Care, Inc.
- Applicants: Roche Diabetes Care, Inc.
- Inventors: Matthias Koehler; Uwe Kraemer; Timm Wiedemann; Marcus Vetter
- Web page: https://patentgrep.com/patent/US20190244702A1

## CPC

- G16H 20/17: delivered via infusion or injection
- A61M 5/31568: {Means keeping track of the total dose administered, e.g. since the cartridge was inserted}
- G16H 40/63: for local operation
- A61M 5/3155: {by rotational movement of dose setting member, e.g. during setting or filling of a syringe}
- A61M 2205/0244: Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
- A61M 2205/332: Force measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3365: Rotational speed
- A61M 2205/3569: sublocal, e.g. between console and disposable
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- A61M 2205/6009: for matching patient with his treatment, e.g. to improve transfusion security
- A61M 2205/702: automatically during use
- A61M 2205/8206: battery-operated
- A61M 2205/8212: with means or measures taken for minimising energy consumption
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

The invention concerns a device (1) for generating protocol data for an injection pen (2). The device (1) comprises a motion sensing unit (13) including one or more of a gyroscope and an accelerometer in order to generate one or more of a gyro signal and an acceleration signal. The device comprises a signal processing unit (14) which implements an analyser which is configured to analyse one or more of the gyro signal and the acceleration signal and to generate protocol data reflecting an adjusted dosage of a medicament. Optionally, the analyser is configured to generate protocol data reflecting delivery of the adjusted dosage of the medicament.

## Claims

### Claim 1

A device for generating protocol data for an injection pen, wherein the device comprises a motion sensing unit including one or more of a gyroscope, and an accelerometer in order to generate one or more of a gyro signal and an acceleration signal, and wherein the device comprises a signal processing unit which implements an analyser which is configured to analyse one or more of the gyro signal and the acceleration signal, and to generate protocol data reflecting an adjusted dosage of a medicament and optionally to generate protocol data reflecting delivery of the adjusted dosage of the medicament.

### Claim 2 (depends on 1)

The device according to claim 1, wherein the analyser is adaptable to different types of injection pens.

### Claim 3 (depends on 1)

The device according to claim 1, wherein the analyser is configured to adapt itself to the corresponding injection pen.

### Claim 4 (depends on 1)

The device according to claim 1, wherein the device includes a universal part which can be used with different types of injection pens and an adapter part which is designed to adapt the universal part to a particular type of injection pens.

### Claim 5 (depends on 1)

The device according to claim 1, wherein the analyser is adaptable to an injection pen on the basis of a training sequence of a user.

### Claim 6 (depends on 1)

The device according to claim 1, further comprising a communication interface for transmitting generated protocol data to an external protocol data recording device.

### Claim 7 (depends on 1)

The device according to claim 1, wherein the analyser is configured to generate protocol data having included a time stamp.

### Claim 8 (depends on 1)

The device according to claim 1, wherein the analyser is configured to analyse one or more of the gyro signal and the acceleration signal in order to determine one or more of an angular velocity and a derivative, of the angular velocity of a dosing adjusting means of the injection pen and to generate protocol data on the basis of one or more of the angular velocity and the derivative of the angular velocity of the dosing adjusting means of the injection pen.

### Claim 9 (depends on 1)

The device according to claim 1, wherein the analyser implements a data ring buffer which receives at least one of the gyro signal and the acceleration signal and which provides data segments in accordance to a peak detection in at least one of the gyro signal and the acceleration signal.

### Claim 10 (depends on 1)

The device according to claim 1, wherein, for the analysis of at least one of the gyro signal and the acceleration signal, the analyser implements a signal vector which comprises one or more of the following components: an x-component of the gyro signal, a y-component of the gyro signal, a z-component of the gyro signal, a derivative with respect to time of an x-component of the gyro signal, a derivative with respect to time of an y-component of the gyro signal, a derivative with respect to time of an z-component of the gyro signal, an x-component of the acceleration signal, a y-component of the acceleration signal, a z-component of the acceleration signal, a derivative with respect to time of an x-component of the acceleration signal, a derivative with respect to time of an y-component of the acceleration signal, a derivative with respect to time of an z-component of the acceleration signal, a projection of the gyro signal, a peak position in the gyro signal, and a signal length of at least one of the gyro signal and the acceleration signal.

### Claim 11 (depends on 1)

The device according to claim 1, wherein, for the analysis of at least one of the gyro signal and the acceleration signal, the analyser implements a feature calculation for one or more components of at least one of the gyro signal and the acceleration signal, wherein the feature calculation includes one or more of: the calculation of the absolute maximum value in a signal segment, the calculation of the sum of the values of a signal segment, the calculation of the sum from the start to an absolute maximum position of a signal segment, the calculation of the sum from an absolute maximum position to the end of a signal segment, the calculation of the sum from the start to a peak position of a signal segment, the calculation of the sum from a peak position to the end of a signal segment, the calculation of the difference between the maximum and the minimum of a signal segment, and the calculation of the difference between the absolute maximum and the mean of a signal segment.

### Claim 12 (depends on 1)

The device according to claim 1, wherein, for the analysis of at least one of the gyro signal and the acceleration signal, the analyser implements a classifier in one or more of the following forms: a random forest classifier, and a support vector machine.

### Claim 13 (depends on 1)

The device according to claim 1, wherein the analyser is configured to analyse one or more of the gyro signal and the acceleration signal in order to determine a motion sequence of the injection pen and to switch the device from a low energy mode into a high energy mode if the motion sequence corresponds to a predefined motion sequence.

### Claim 14 (depends on 1)

Injection pen comprising a device according to claim 1.

### Claim 15 (depends on 14)

Injection pen according to claim 14, wherein the device is fixedly mounted to the injection pen.