Monitoring device

• US 10,773,032 B2
• Filed: 03/13/2015
• Issued: 09/15/2020
• Est. Priority Date: 03/14/2014
• Status: Active Grant

• Current Assignee: Shl Medical AG
• Original Assignee: Shl Medical AG
• Inventors: Cirillo, William Robert, Hughes, John Pascal
• Primary Examiner(s): Bouchelle, Laura A
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US15/125,996
• Publication Number:
  US 20170189625A1
• Time in Patent Office: 2,013 Days
• CPC Class Codes: A61M 2005/3126 Specific display means related to dosing
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2209/08 Supports for equipment
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: A61M 5/3155 by rotational movement of dose setting member, e.g. during setting or filling of a syringe
• CPC Class Codes: A61M 5/31568 Means keeping track of the total dose administered, e.g. since the cartridge was inserted
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G01D 5/34 the beams of light being detected by photocells

Abstract

A smart monitoring device for automatically monitoring the injection of medicines such as insulin which can be retrofitted to a conventional insulin pen in which the device has an optical motion sensor for detecting actuation of the injection pen together with an optional accelerometer sensor, medicament temperature and mounting sensors, the monitoring device being communicable with external smart devices such as smartphones.

Claims

1. A monitoring device for monitoring the injection of a medicine using an injection device, the monitoring device comprising:

a sleeve configured to be removably mounted to an injection device, where the sleeve comprises;

an annular shape having an elongate slit used to removably mount the sleeve to the injection device; and

an elongate rail having a pen identifier,

a housing comprising;

an optical motion detection system that passively detects both rotational and longitudinal continuous movement of a shaft of the injection device relative to a body housing of the injection device using an optical sensor as the shaft moves distally and axially outward from the body housing during dose setting and as the shaft moves proximally and axially back into the body housing during dose delivery when the housing and sleeve is attached to an outside surface of the body housing of the injection device, where the housing is rotationally and axially fixed relative to the body housing such that all components of motion detection system are contained within the housing and do not move relative to the body housing, where the optical sensor is positioned such that it projects over the shaft to track both the axial and rotational movement of the shaft in a proximal direction during injection of a set dose of medicine and in a distal direction during dose setting; and

a complimentary rail configured to removably engage with the elongate rail such that when engaged, the housing and the sleeve are securely attached and the pen identifier is in operative communication with the optical motion detection system,

wherein the detection of the shaft movement does not involve mechanical movement of any part of the motion detection system.

2. The monitoring device as claimed in claim 1 wherein the optical sensor is selected from the group comprising a visible light, infra red, laser, ultra violet, and LED optical sensors.

3. The monitoring device as claimed in claim 1 wherein the optical motion detection system comprises a memory, a CPU and a display communicable with the optical sensor.

4. The monitoring device as claimed in claim 3 wherein the optical motion detection system comprises a communications module for communicating between the monitoring device and an external smart device.

5. The monitoring device as claimed in claim 4 wherein the communications module comprises a Bluetooth communications module.

6. The monitoring device as claimed in claim 4 wherein the external smart device is selected from the group comprising a smartphone, computer or handheld device.

7. The monitoring device as claimed in claim 1 wherein the device further comprises an accelerometer sensor that detects movement of the shaft during dose delivery through sensing vibration of the injection device such that the monitoring device distinguishes dose setting or dose adjustment from actual dose injection.

8. The monitoring device as claimed in claim 1 wherein the device further comprises a temperature sensor for monitoring the temperature of the medicine.

9. The monitoring device as claimed in claim 1 wherein the monitoring device comprises an attachment means for retrofitting the monitoring device to an injection device to create a smart injection device.

10. The monitoring device as claimed in claim 9 wherein the attachment means comprises a detachable attachment means.

11. The monitoring device as claimed in claim 1 wherein the sleeve is unique to the injection device.

12. The monitoring device as claimed in claim 11 wherein the injection device identifier comprises a projection on the sleeve.

13. The monitoring device as claimed in claim 12 wherein the monitoring device comprises an injection device identifier sensor.

14. The monitoring device as claimed in claim 13 wherein the injection device identifier sensor comprises a pressure sensor.

15. The monitoring device as claimed in claim 1 wherein the injection device comprises an injection pen.

16. An injection pen comprising a device as claimed in claim 1.

17. The injection pen as claimed in claim 16 wherein the injection pen is an insulin injection pen.

18. The monitoring device as claimed in claim 1 further comprises a plurality pressure sensor switches that engage projections on the sleeve when the monitoring device housing is attached to the sleeve.

19. A monitoring device for removable attachment to a pen type injection device, where the monitoring device comprises:

a housing comprising an optical motion detection system that passively detects both rotational and directional movement of a part of an injection device using an optical sensor when the housing is attached to an outside surface of a body housing of the injection device, where the housing is rotationally and axially fixed relative to the body housing such that all components of motion detection system are contained within the housing and do not move relative to the body housing, where the optical sensor is positioned such that it projects over the moving part of the injection device to track both the axial and rotational movement of the part in a proximal direction during injection of a set dose and the axial movement of part of the injection device in a distal direction relative to the body housing during dose setting; and

a removable mounting device that releasably attaches to the body housing of the injection device and to the monitoring device housing, where the monitoring device housing further comprises a plurality sensor switches that engage projections on the mounting device when the monitoring device housing is attached to the mounting device,

wherein the engagement of the sensor switches with the projections allows the pen type injection device to be identified.