# US 11,439,764 B2 · Monitoring device

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- Number: US 11,439,764 B2
- Document ID: US11439764B2
- Status: Granted
- Kind: B2
- Application number: 16/489,432
- Filed: 2018-02-27
- Published: 2020-01-09
- Granted: 2022-09-13
- Earliest claimed: 2017-02-28
- Assignees: Shl Medical AG
- Applicants: SHL Medical AG
- Inventors: William Cirillo
- Web page: https://patentgrep.com/patent/US11439764B2

## CPC

- A61M 5/31533: {Dosing mechanisms, i.e. setting a dose (administrating mechanisms A61M5/31565)}
- A61M 5/31568: {Means keeping track of the total dose administered, e.g. since the cartridge was inserted}
- A61M 5/009: {Electronic or electro-mechanical add-on modules}
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 5/31556: {Accuracy improving means}
- A61M 5/31573: {Accuracy improving means}
- A61M 2005/3126: {related to dosing}
- A61M 2005/3142: {Modular constructions, e.g. supplied in separate pieces to be assembled by end-user}
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3306: Optical measuring means
- A61M 2205/3327: Measuring
- A61M 2205/3368: Temperature
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- 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 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/581: by audible feedback
- 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 present invention relates to a monitoring device (10) arranged to be operably connected to a medicament delivery device (12), said medicament delivery device (12) comprising a manually operated movable dose activation element (20), said monitoring device (10) comprising an electronic circuit (42), said electronic circuit (42) comprising an optical sensor (68), wherein said optical sensor (68) is positioned in relation to said dose activation element (20) so as to detect a manual operation of said dose activation element (20) from an initial position; said electronics circuit further comprising a vibration sensor (70), wherein said vibration sensor (70) is positioned in relation to said medicament delivery device so as to detect specific vibration spectra produced by the medicament delivery device when said dose activating element (20) is operated, wherein said electronic circuit (42) comprises computing elements capable of correlating the information from the optical sensor (68) with the information from the vibration sensor (70) when said dose activation element (20) is operated in order to register when a correct dose has been set.

## Claims

### Claim 1

A monitoring device arranged to be operably connected to a medicament delivery device including a manually operated movable dose activation element, said monitoring device comprising:
a housing defining a passage, said passage having a first end configured to be positioned adjacent said medicament delivery device and a second end opposite the first end; and
an electronic circuit, said electronic circuit comprising an optical sensor for measuring a movement of the dose activation element,
wherein said optical sensor is positioned adjacent the second end of said passage and in line with said passage such that said optical sensor is spaced away from a surface of the dose activation element,
wherein said optical sensor is arranged to scan the surface of the dose activation element through said passage so as to detect a movement of said dose activation element from an initial position,
said electronic circuit further comprising a vibration sensor,
wherein said vibration sensor is positioned in relation to said medicament delivery device so as to detect specific vibration spectra produced by the medicament delivery device when said dose activation element is operated,
wherein said electronic circuit comprises computing elements capable of correlating the information from the optical sensor with the information from the vibration sensor when said dose activation element is operated in order to register when a correct dose has been set,
wherein the specific vibration spectra is produced by the medicament delivery device at predetermined dose quantity intervals,
wherein said vibration sensor is an accelerometer, and
wherein the accelerometer is arranged to detect and record audible clicks corresponding to the predetermined dose quantity intervals as a dose of medicament is set by a user turning the dose activation element.

### Claim 2 (depends on 1)

The monitoring device according to claim 1, further comprising a user information interface capable of providing information to the user.

### Claim 3 (depends on 2)

The monitoring device according to claim 2, wherein the user information interface comprises a display.

### Claim 4 (depends on 1)

The monitoring device according to claim 1, further comprising a touch sensor.

### Claim 5 (depends on 1)

The monitoring device according to claim 1, further comprising a temperature sensor.

### Claim 6 (depends on 4)

The monitoring device according to claim 4, wherein the touch sensor is operably connected to the electronic circuit such that the electronic circuit is activated when the touch sensor detects a touch or movement of the monitoring device.

### Claim 7 (depends on 5)

The monitoring device according to claim 5, wherein the temperature sensor is operably connected to the electronic circuit such that an indication is provided when a temperature detected by the temperature sensor has reached a certain level.

### Claim 8 (depends on 1)

The monitoring device according to claim 1, further comprising at least one communication circuit designed and arranged to communicate with external communication elements.

### Claim 9 (depends on 8)

The monitoring device according to claim 8, wherein said communication circuit comprises near range communication technology.

### Claim 10 (depends on 8)

The monitoring device according to claim 8, wherein said communication circuit comprises wireless local area network communication technology.

### Claim 11 (depends on 8)

The monitoring device according to claim 8, wherein said communication circuit comprises digital cellular network communication technology.

### Claim 12

A system for monitoring an operation of a medicament delivery device, said medicament delivery device comprising a manually operated movable dose activation element, said system comprising:
a connecting element arranged with a first fixation, which said first fixation is configured to removably connect to a support surface of said medicament delivery device, the connecting element further including a second fixation; and
a monitoring unit arranged with a housing defining a passage and an attachment element, which said attachment element is configured to interact with the second fixation, wherein said passage includes a first end configured to be positioned adjacent said medicament delivery device and a second end opposite the first end;
said monitoring device comprising an electronic circuit,
said electronic circuit comprising an optical sensor and a vibration sensor, wherein said vibration sensor is positioned in relation to said medicament delivery device so as to detect specific vibration spectra produced by the medicament delivery device when said dose activating element is operated,
wherein said optical sensor is positioned adjacent the second end of said passage and in line with said passage such that said optical sensor is spaced away from a surface of the dose activation element,
wherein said optical sensor is positioned in relation to said dose activation element so as to scan the surface of said dose activation element through said passage so as to detect a movement of said dose activation element,
wherein said electronic circuit comprises computing elements capable of correlating the information from the optical sensor with the information from the vibration sensor when said dose activation element is operated in order to register when a correct dose has been set,
wherein the specific vibration spectra is produced by the medicament delivery device at predetermined dose quantity intervals,
wherein said vibration sensor is an accelerometer, and
wherein the accelerometer is arranged to detect and record audible clicks corresponding to the predetermined dose quantity intervals as a dose of medicament is set by a user turning the dose activation element.

### Claim 13 (depends on 12)

The system according to claim 12, wherein the connecting element is an annular sleeve.

### Claim 14 (depends on 12)

The system according to claim 12, wherein the manually operated movable dose activation element further comprises a tubular extension, wherein said optical sensor is configured to detect the movement of said tubular extension.
