Medical system having consumables monitoring

• US 8,517,938 B2
• Filed: 04/26/2010
• Issued: 08/27/2013
• Est. Priority Date: 10/24/2007
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Eisenhardt, Christoph, Huellen, Volker, Kube, Oliver, Roeper, Josef, Ziegler, Friedrich
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US12/767,579
• Publication Number:
  US 20110112384A1
• Time in Patent Office: 1,219 Days
• Field of Search: 600/300, 600/309, 600/310, 600/316, 600/347, 422/68.1, 435/4, 435/14, 340/539.12, 702/19
• US Class Current: 600/300
• CPC Class Codes: A61B 2017/00482 with a code
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 90/96 : using barcodes
• CPC Class Codes: A61B 90/98 : using electromagnetic means, e.g. transponders

Abstract

The invention proposes a medical system which comprises a central control unit which is set up to display at least one diagnostic measured value using a display element. The medical system also comprises at least one invasive unit, wherein the invasive unit has at least one invasive consumable. The invasive consumable is set up to invasively intervene in a tissue of a patient. The invasive unit has at least one contactlessly readable electronic identifier for storing at least one piece of information. The central control unit is set up to electronically read the at least one piece of information in the electronic identifier. The central control unit and the invasive unit are functionally independent of one another such that the respective function of the central control unit and of the invasive unit can be performed independently of the presence of the respective other unit.

Claims

1. A medical system comprising a central control unit configured to display a diagnostic measured value using a display element and an invasive unit comprising an invasive consumable, wherein the invasive consumable is configured to invasively intervene in a tissue of a patient, wherein the invasive unit has a contactlessly readable electronic identifier for storing a piece of information, wherein the central control unit is set up to electronically read said piece of information in the electronic identifier and perform an action responsive to said piece of information, wherein the central control unit and the invasive unit are functionally independent of one another such that the central control unit has a function which can be used by the user without the presence of the invasive unit and conversely the function of the invasive unit can be used by the user without the need for the central control unit to be present for this purpose, the respective function of the central control unit and of the invasive unit being capable of being performed independently of the presence of the respective other unit, wherein the central control unit has a measuring unit which is set up to use at least one test element to ascertain a concentration of an analyte in a body fluid, wherein the measuring unit is selected from the group consisting of an optical measuring unit and an electrochemical measuring unit.

2. The medical system as claimed in claim 1, wherein the invasive unit has a function selected from the group consisting of:

a lancet function;

a dosage function;

an analytical function which is functionally independent of the measurement function of the central control unit; and

a diagnostic function which is functionally independent of the measurement function of the central control unit.

3. The medical system as claimed in claim 2, wherein the invasive unit is configured to perform exclusively mechanical functions.

4. The medical system as claimed in claim 1, wherein the invasive unit further comprises a unit selected from the group consisting of:

a peripheral device in the form of a lancing device, wherein the lancing device is designed to perforate a skin part of a patient using an invasive consumable in the form of a lancet;

a peripheral device in the form of a medication pen, wherein the medication pen is designed to inject a dose of a medicament into a patient using an invasive consumable in the form of a cannula;

a peripheral device in the form of a medication pump, wherein the medication pump is designed to inject a dose of a medicament into a patient using an invasive consumable in the form of a catheter; and

a peripheral device in the form of a measuring unit, wherein the measuring unit is designed to use an invasive consumable comprising a subcutaneous sensor implanted in a body tissue of a patient, to ascertain a concentration of an analyte in a body fluid.

5. The medical system as claimed in claim 1, wherein the central control unit is set up to take the information read as a basis for transmitting a cue to the user, wherein the cue is selected from the group of cues consisting of:

an audible cue;

a visual cue; and

a haptic cue.

6. The medical system as claimed in claim 1, wherein the information comprises one of the pieces of information selected from the group consisting of:

a piece of information about a manufacturer of the invasive unit;

a piece of information about a manufacturer of the peripheral device;

a piece of information about a manufacturer of the invasive consumable;

a piece of information about a date of manufacture of the invasive unit;

a piece of information about a date of manufacture of the peripheral device;

a piece of information about a date of manufacture of the invasive consumable;

a piece of information about the type of the invasive unit;

a piece of information about the type of the peripheral device;

a piece of information about the type of the invasive consumable;

an individual serial number;

a number of invasive consumables contained in the invasive unit;

an expiry date for the invasive unit;

an expiry date for the peripheral device; and

an expiry date for the invasive consumable.

7. The medical system as claimed in claim 1, wherein the invasive unit additionally has a peripheral device, wherein the peripheral device is set up to interact with the invasive consumable.

8. The medical system as claimed in claim 7, wherein the invasive consumable has a first contactlessly readable electronic identifier for storing a first piece of information, wherein the peripheral device has a second contactlessly readable electronic identifier for storing a second piece of information.

9. The medical system as claimed in claim 8, wherein the central control unit is set up to read the first piece of information and the second piece of information.

10. The medical system as claimed in claim 8, wherein the central control unit is set up to compare the first piece of information with a first piece of target information and to compare the second piece of information with a second piece of target information.

11. The medical system as claimed in claim 1, wherein a plurality of invasive consumables are combined in a consumables magazine in the invasive unit.

12. The medical system as claimed in one of the preceding claims, wherein the action is selected from the group consisting of:

storing for later evaluation;

evaluating for error diagnosis;

providing the piece of information for a user;

outputting a warning to a user if the piece of information differs from a target value or target range;

storing a piece of warning information in a data memory;

disabling a device function of the central control unit if the piece of information differs from a target value or target range;

ascertaining when the invasive consumable in the invasive unit was last changed;

ascertaining a manufacturer of the invasive unit; and

ascertaining a manufacturer of the invasive consumable.

13. The medical system as claimed in claim 1, wherein the central control unit comprises a first interface for data interchange with an external data processing device and wherein the central control unit comprises a second interface for interchanging the piece of information with an identifier.

14. The medical system as claimed in claim 13, wherein the identifier comprises a passive identifier without its own power supply.

15. The medical system as claimed in claim 1, wherein the electronic identifier comprises an identifier selected from the group consisting of:

an electronic bar code;

a variable identifier;

a position-sensitive identifier for identifying a position of the invasive consumable within the invasive unit;

a position-sensitive identifier for identifying an orientation of the invasive consumable within the invasive unit; and

a radio-frequency chip.

16. A method for monitoring a medical system, comprising providing a medical system comprising a central control unit configured to display a diagnostic measured value using a display element and an invasive unit comprising an invasive consumable and a contactlessly readable electronic identifier for storing at least one piece of information;

invasively intervening the invasive consumable in a tissue of a patient;

reading the at least one piece of information in the electronic identifier with the central control unit and performing an action responsive to said piece of information; and

functioning the central control unit and the invasive unit independently of one another such that the central control unit has a function which can be used by the user without the presence of the invasive unit and conversely the function of the invasive unit can be used by the user without the need for the central control unit to be present for this purpose, the respective functioning of the central control unit and of the invasive unit being performed independently of the presence of the respective other unit, wherein the central control unit has a measuring unit which is set up to use at least one test element to ascertain a concentration of an analyte in a body fluid, wherein the measuring unit is selected from the group consisting of an optical measuring unit and an electrochemical measuring unit.

17. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information whether the invasive consumable has already been used previously in the medical system.

18. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information whether an expiry date has lapsed, wherein the expiry date is selected from the group consisting of:

an expiry date for the invasive unit; and

an expiry date for the invasive consumable.

19. The method as claimed in claim 16, wherein performing an action comprises storing the piece of information for later evaluation in a data memory of the central control unit.

20. The method as claimed in claim 19, wherein performing an action comprises evaluating the piece of information in the course of one or both of an error diagnosis and a complaint.

21. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information a suitability, wherein the suitability is selected from the group consisting of:

a suitability of the invasive unit for use in the medical system; and

a suitability of the invasive consumable for use in the medical system.

22. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information how many invasive consumables the invasive unit comprises.

23. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information how many unused invasive consumables the invasive unit comprises.

24. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information whether the invasive consumable has already been used, and performing an action if it is ascertained that the invasive consumable has already been used, the action comprising one of prompting the user to use a new invasive consumable and ensuring that the invasive unit uses a new invasive consumable.

25. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to store information about an identity of the central control unit in the identifier.

26. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information whether the invasive consumable is correctly positioned in the invasive unit.

27. The method as claimed in claim 16, wherein performing an action comprises using the central control unit to ascertain from the piece of information when the last change of the invasive consumable occurred.

28. The method as claimed in claim 27, further comprising outputting a warning to a user if a maximum time since the last change of the invasive consumable has been exceeded.

29. The method as claimed in claim 16, wherein the invasive consumable comprises at least one lancet, wherein the invasive unit comprises a peripheral device in the form of a lancing device, wherein performing an action comprises using the central control unit to ascertain from the piece of information what depth of prick is set on the lancing device.