BLOOD GLUCOSE TEST INSTRUMENT KIT HAVING MODULAR COMPONENT PARTS

• US 20120094370A1
• Filed: 10/15/2010
• Published: 04/19/2012
• Est. Priority Date: 10/15/2010
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Werner, Karl, Seelig, Peter, Porsch, Ulrich, Ramey, Blaine E., Wilson, Richard W., Niesporek, Christian, Schmitz, Ralf, Schwenker, Kai-Oliver
• Granted Patent: US 8,383,056 B2
• Time in Patent Office: Days
• US Class Current: 435/288.7
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• 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 5/150305 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 5/150854 long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150877 with implanted devices
• CPC Class Codes: A61B 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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: G16H 40/63 for local operation

Abstract

A blood glucose test instrument kit having modular component parts capable of being assembled into a plurality of different handheld blood glucose test instruments is disclosed. The kit comprises the combination of an interconnection platform adapted to connect to a collection of interoperable modules. The collection of interoperable modules including: a plurality of different measurement engine modules, at least one user interface module, at least one power supply module. A handheld blood glucose test instrument is assembled by the interconnection to the interconnection platform of at least one measurement engine module, at least one user interface module, and at least one power supply module. The inter-module communication among the modules connected thereto to achieve enhanced glucose test instrument reliability by effecting at least one reliability protocol selected from a group of reliability protocols.

Claims

1. A blood glucose test instrument kit having modular component parts capable of being assembled into a plurality of different handheld blood glucose test instruments, the kit comprising the combination of:

an interconnection platform adapted to fit within a portable housing that supports at least one display device;

a collection of interoperable modules, each of the modules having an interface adapted for connection to the interconnection platform, the collection of interoperable modules including;

a plurality of different measurement engine modules each having an input port to receive a blood sample carrier and producing blood test data;

at least one user interface module adapted to couple to said display device and containing test logic for implementing at least one blood glucose test protocol;

at least one power supply module adapted, when connected to said interconnection platform, to provide operating power to other modules that are connected to said interconnection platform;

wherein a handheld blood glucose test instrument is assembled by the interconnection to the interconnection platform of at least one measurement engine module, at least one user interface module, and at least one power supply module;

the interconnection platform providing inter-module communication among the modules connected thereto to achieve enhanced glucose test instrument reliability by effecting at least one reliability protocol selected from the group consisting of;

(a) a connected measurement engine module from the plurality of measurement engine modules cooperating with a user interface module to instruct the user to remove the blood sample carrier when the measurement engine module detects the blood sample carrier is damaged;

(b) the connected measurement engine module cooperating with the user interface module to instruct the user to insert a new code key, when the measurement engine module detects that a previously entered code key is incorrect; and

(c) the connected measurement engine module cooperating with the user interface module to instruct the user to repeat an attempted blood glucose test when the connected measurement engine module detects that an insufficient amount of blood or control solution has been deposited was deposited on blood sample carrier.

2. The blood glucose test instrument kit of claim 1, wherein the group of reliability protocols further comprises the connected measurement engine module cooperating with the user interface module to instruct the user to repeat an attempted blood glucose test when the connected measurement engine module detects that the user failed to adhere to a sequence defined in the blood glucose test protocol.

3. The blood glucose test instrument kit of claim 1, wherein the group of reliability protocols further comprises the connected measurement engine module cooperating with the user interface module to instruct the user to repeat an attempted blood glucose test when the connected measurement engine module detects that an ambient temperature outside of the connected measurement engine module is not within a predefined temperature.

4. The blood glucose test instrument kit of claim 1, wherein the collection of modules further include at least one data management module for storing data based upon said blood test data, and wherein the handheld blood glucose test instrument is further assembled by the interconnection to the interconnection platform of the data management module.

5. The blood glucose test instrument kit of claim 4, wherein the group of reliability protocols further comprises the user interface module cooperating with the connected measurement engine module and the data management module to suppress generation of blood test data when an expiry date of a reagent used in the blood sample carrier has been passed and to communicate a fault condition message to the user.

6. The blood glucose test instrument kit of claim 4, wherein the group of reliability protocols further comprises the user interface module cooperating with the data management module and the measurement engine module to suppress the storing of data based upon said blood test data when the measurement engine module detects a fault condition at the blood sample carrier site.

7. The blood glucose test instrument kit of claim 1, wherein the group of reliability protocols further comprises the power supply module cooperating with the connected measurement engine module and the user interface module to communicate a fault condition message to the user when power supply module resources are insufficient to reliably produce blood test data.

8. The blood glucose test instrument kit of claim 1, wherein the collection of modules further include at least one communication module adapted to provide connectivity between the blood glucose test instrument and a separate therapy system, and wherein the handheld blood glucose test instrument is further assembled by the interconnection to the interconnection platform of the at least one communication module.

9. The blood glucose test instrument kit of claim 8, wherein the group of reliability protocols further comprises the power supply module cooperating with the communication module and the user interface module to communicate a fault condition message to the user interface module when power supply module resources are insufficient to reliably communicate with a separate therapy system.

10. The blood glucose test instrument kit of claim 1, wherein the plurality of different measurement engine modules includes a first measurement engine module that performs electrochemical sensing and a second measurement engine module that performs optical sensing.

12. The blood glucose test instrument kit of claim 1, wherein the group of reliability protocols further comprises the connected measurement engine module cooperating with the user interface module to instruct the user to repeat an attempted blood glucose test when the connected measurement engine module detects that the user failed to adhere to a sequence defined in the blood glucose test protocol.

11. A blood glucose test instrument kit having modular component parts capable of being assembled into a plurality of different handheld blood glucose test instruments, the kit comprising the combination of:

an interconnection platform adapted to fit within a portable housing that supports at least one display device;

a collection of interoperable modules, each of the modules having an interface adapted for connection to the interconnection platform, the collection of interoperable modules including;

a plurality of different measurement engine modules each having an input port to receive a blood sample carrier and producing blood test data;

at least one user interface module adapted to couple to said display device and containing test logic for implementing at least one blood glucose test protocol;

at least one power supply module adapted, when connected to said interconnection platform, to provide operating power to other modules that are connected to said interconnection platform;

at least one communication module adapted to provide connectivity between the blood glucose test instrument and a separate therapy system; and

at least one data management module for storing data based upon said blood test data;

wherein a handheld blood glucose test instrument is assembled by the interconnection to the interconnection platform of at least one measurement engine module, at least one user interface module, at least one power supply module, at least one communication module and at least one data management module;

the interconnection platform providing inter-module communication among the modules connected thereto to achieve enhanced glucose test instrument reliability by effecting at least one reliability protocol selected from the group consisting of;

(a) a connected measurement engine module from the plurality of measurement engine modules cooperating with a user interface module to instruct the user to remove the blood sample carrier when the measurement engine module detects the blood sample carrier is damaged;

(b) the connected measurement engine module cooperating with the user interface module to instruct the user to insert a new code key, when the measurement engine module detects that a previously entered code key is incorrect; and

(c) the connected measurement engine module cooperating with the user interface module to instruct the user to repeat an attempted blood glucose test when the connected measurement engine module detects that an insufficient amount of blood or control solution has been deposited was deposited on blood sample carrier.

13. The blood glucose test instrument kit of claim 11, wherein the group of reliability protocols further comprises the connected measurement engine module cooperating with the user interface module to instruct the user to repeat an attempted blood glucose test when the connected measurement engine module detects that an ambient temperature outside of the connected measurement engine module is not within a predefined temperature.

14. The blood glucose test instrument kit of claim 11, wherein the group of reliability protocols further comprises the user interface module cooperating with the connected measurement engine module and the data management module to suppress generation of blood test data when an expiry date of a reagent used in the blood sample carrier has been passed and to communicate a fault condition message to the user.

15. The blood glucose test instrument kit of claim 11, wherein the group of reliability protocols further comprises the user interface module cooperating with the data management module and the measurement engine module to suppress the storing of data based upon said blood test data when the measurement engine module detects a fault condition at the blood sample carrier site.

16. The blood glucose test instrument kit of claim 11, wherein the group of reliability protocols further comprises the power supply module cooperating with the connected measurement engine module and the user interface module to communicate a fault condition message to the user when power supply module resources are insufficient to reliably produce blood test data.

17. The blood glucose test instrument kit of claim 11, wherein the group of reliability protocols further comprises the power supply module cooperating with the communication module and the user interface module to communicate a fault condition message to the user interface module when power supply module resources are insufficient to reliably communicate with a separate therapy system.

18. The blood glucose test instrument kit of claim 11, wherein the plurality of different measurement engine modules includes a first measurement engine module that performs electrochemical sensing and a second measurement engine module that performs optical sensing.