Device, a system and a method for identification/authentication of parts of a medical device

• US 9,138,531 B2
• Filed: 05/27/2009
• Issued: 09/22/2015
• Est. Priority Date: 05/29/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Keret, Avihoo P.
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US12/995,068
• Publication Number:
  US 20110118694A1
• Time in Patent Office: 2,309 Days
• Field of Search: 604/890.1, 604/500, 604/502, 604/503, 604/504, 604/506, 604 65- 67
• US Class Current: 1/1
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

Disclosed is a dispensing system. The dispensing system includes a dispensing unit to dispense therapeutic fluid, and a validation mechanism to enable operation of the dispensing unit based, at least in part, on a determination of whether operation of the dispensing device is authorized.

Claims

1. A system for dispensing insulin into a body of a user, the device system comprising:

a cradle unit configured to attach to the body of the user;

a first portion configured for removable attachment to the cradle unit, the first portion having at least a portion of a driving mechanism, a processor and at least one ID reader;

a second portion having a reservoir and at least one ID marker; and

a disabling mechanism configured to mechanically disable the at least one ID marker by direct physical contact with the at least one ID marker which damages functionality of the at least one ID marker to render the at least one ID marker unreadable by the at least one ID reader,

the disabling mechanism operated based on a determination by the processor of the corresponding signal received from the at least one ID reader;

wherein upon connection of the first portion to the second portion the at least one ID reader reads the at least one ID marker for authenticating the second portion and provides a corresponding signal to the processor as a result of such reading, and

wherein operation of the system is enabled by the processor based on the corresponding signal confirming authentication of the second portion.

2. The system of claim 1, wherein the second portion further includes a power source, and upon connection of the first portion to the second portion power is provided from the power source to at least the driving mechanism, the processor and the at least one ID reader.

3. The system of claim 1, wherein one or more functions of the system are enabled by the processor based on the corresponding signal, the one or more functions being selected from the group consisting of:

inserting a cannula into the body of a user, dispensing a therapeutic fluid to the body of the user, setting an amount of a therapeutic fluid for delivery to the body of the user, replacing a reservoir, assembling a dispensing unit, and stopping a delivery of a therapeutic fluid to the body of the user.

4. The system of claim 1, wherein the first portion is a reusable part and the second portion is a disposable part and configured for removable attachment to the cradle unit.

5. The system of claim 1, wherein the second portion is integral with the cradle unit.

6. The system of claim 1, wherein the system further comprises an inserter configured for inserting a cannula into the body of the user, the inserter including a second ID reader configured for communicating with an ID marker located on the cannula and optionally with the at least one ID marker.

7. The system of claim 1, wherein assembly of the first portion to the second portion changes the at least one ID marker.

8. The system of claim 1, wherein the at least one ID reader includes an RFID reader and the at least one ID marker includes an RFID tag.

9. The system of claim 1, wherein the at least one ID marker includes a rewriteable memory.

10. The system of claim 1, wherein the at least one ID marker includes a barcode and the at least one ID reader includes a barcode reader.

11. The system of claim 1, wherein:

the system further includes a database for storing information related to reading of the at least one ID marker;

at least a portion of the corresponding signal received from the at least one ID reader comprises information; and

the processor compares at least some of the information received from the at least one ID reader with at least some of the information stored in the database.

12. The system of claim 1, wherein the disabling mechanism disables subsequent reading of the at least one ID marker after connection between at least one the first portion of the system with at least one the second portion of the system.

13. The system of claim 1, wherein the disabling mechanism operates to push or rub against the at least one ID maker to mechanically disable the at least one ID marker through direct physical contact with the at least one ID marker.

14. A system for dispensing a therapeutic fluid to a body of a user, the system comprising:

a cradle unit configured to attach to the body of the user;

a reservoir for containing the therapeutic fluid;

a cannula insertable into the body of the user for providing at least a portion of a fluid path between the reservoir and the user'"'"'s body;

a driving mechanism configured for removable attachment to the cradle unit, the driving mechanism configured for engaging with the reservoir for dispensing the therapeutic fluid;

a processor controlling the driving mechanism;

at least one ID marker for authenticating at least a portion of the system;

at least one ID reader for reading the at least one ID marker and for providing a signal to the processor based on such reading; and

a power source for providing power to at least one of the driving mechanism, the at least one ID reader and the processor; and

a disabling mechanism configured to mechanically disable the at least one ID marker by direct physical contact with the at least one ID marker which damages functionality of the at least one ID marker to render the at least one ID marker unreadable by the at least one ID reader, the disabling mechanism operated based on a determination by the processor of the corresponding signal received from the at least one ID reader;

wherein the processor enables one or more functions of the system based on the signal received from the at least one ID reader.

15. The system of claim 14, wherein the system includes a dispensing unit which includes the reservoir, the driving mechanism and the at least one ID marker, and a remote control unit which includes the at least one ID reader.

16. The system of claim 14, wherein the system comprises at least two portions, a first portion having the at least one ID marker and a second portion having the at least one ID reader, and wherein the first portion further includes at least one of:

a cannula, a reservoir, the cradle, a tubing enabling fluid communication between the reservoir and the cannula, a vial of therapeutic fluid, a connector configured for enabling fluid communication between a vial of therapeutic fluid and the reservoir, and a probe for measuring analyte levels of the user'"'"'s body.

17. The system of claim 14, wherein the system further comprises a sensor for monitoring analyte levels, wherein the sensor includes a second ID marker and/or a second ID reader.

18. A method for authenticating components of a system for

dispensing a therapeutic fluid to body of a user, the method comprising:

providing a system for dispensing a therapeutic fluid to a body of a user, the system having a cradle unit configured to attach to the body of the user, at least one ID marker, at least one ID reader and a processor controlling one or more functions of the system;

reading the at least one ID marker with the at least one ID reader,

providing a signal from the at least one ID reader to the processor based on the reading of the at least one ID marker, and

enabling the one or more functions of the system according to the signal provided, and

disabling the at least one ID marker with a disabling mechanism which is operated based on a determination by the processor of the signal received from the at least one ID reader, wherein the disabling mechanism is configured to mechanically disable the at least one ID marker by direct physical contact with the at least one ID marker which damages functionality of the at least one ID marker to render the at least one ID marker unreadable by the at least one ID reader.

19. The method of claim 18, further comprising limiting the one or more functions based on the signal.