Kit for determining an analyte concentration

• US 10,806,384 B2
• Filed: 09/01/2016
• Issued: 10/20/2020
• Est. Priority Date: 09/02/2015
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Frey, Stephan-Michael, Kube, Oliver, Heck, Wolfgang, Walter, Helmut
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Mustansir, Abid A
• Application Number:
  US15/754,756
• Publication Number:
  US 20190374138A1
• Time in Patent Office: 1,510 Days
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/225 Connectors or couplings
• 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 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

A kit for determining a concentration of an analyte in a body fluid is disclosed, the kit comprising:

• a) a sensor module comprising
  • i. a sensor adapted to determine the concentration;
  • ii. a control device connected to the sensor comprising a data collection device to collect measurement data acquired by the sensor, the control device further comprising a wireless near-field communication device adapted to transmit measurement data,
• the sensor module comprising a sensor module mechanical interface;
• b) a data reader module adapted to receive measurement data transmitted by the sensor module via wireless near-field communication, the data reader module comprising at least one data storage device;
• c) a data transmission module to receive measurement data transmitted by the sensor module via wireless near-field communication, the data transmission module comprising a wireless far-field communication device to transmit the measurement data to an external device.

Claims

1. A kit for determining a concentration of at least one analyte in a body fluid of a user, the kit comprising:

a) a sensor module comprising

i. at least one sensor element adapted to determine the concentration of the analyte, wherein the sensor element is at least partly implantable into a body tissue of the user;

ii. at least one control device connected to the sensor element, wherein the control device comprises at least one data collection device adapted to collect measurement data acquired by using the sensor element, wherein the control device further comprises at least one wireless near-field communication device adapted to transmit measurement data,

wherein the sensor module comprises a sensor module mechanical interface;

b) at least one data reader module adapted to receive measurement data transmitted by the sensor module via wireless near-field communication, wherein the data reader module comprises at least one data storage device and is adapted to store the measurement data;

c) at least one data transmission module adapted to receive measurement data transmitted by the sensor module via wireless near-field communication, wherein the data transmission module comprises at least one wireless far-field communication device,

wherein the wireless far-field communication device is adapted to transmit at least part of the measurement data to an external device via wireless far-field communication;

wherein the data reader module and the data transmission module are separate components and each comprises a mechanical interface adapted to reversibly engage the sensor module mechanical interface, thereby alternatively generating a fixed spatial relationship between the sensor module and the data reader module or the sensor module and the data transmission module.

2. The kit according to claim 1, wherein the kit further comprises:

d) at least one alarm module adapted to receive data transmitted by the sensor module via wireless near-field communication, wherein the data transmitted by the sensor module contain one or both of measurement data or alarm instructions, wherein the alarm module is adapted to generate at least one alarm signal in response to the data transmitted by the sensor module, wherein the alarm module comprises a mechanical interface adapted to reversibly engage the sensor module mechanical interface, as an alternative to the data reader module and the data transmission module, thereby generating a fixed spatial relationship between the sensor module and the alarm module.

3. The kit according to claim 2, wherein the data transmitted by the sensor module contain measurement data, wherein the alarm module is adapted to evaluate the measurement data and to determine whether at least one alarm condition is fulfilled and to provide the alarm signal in case the at least one alarm condition is fulfilled.

4. The kit according to claim 1, wherein the kit further comprises:

e) a portable data management device, wherein the portable data management device is adapted to directly or indirectly receive the measurement data and to at least partially display data.

5. The kit according to claim 4, wherein the portable data management device is adapted to receive the measurement data from the data transmission module via wireless far-field communication.

6. The kit according to claim 4, wherein the portable data management device is adapted to receive measurement data directly from the sensor module via wireless near-field communication.

7. The kit according to claim 1, wherein the wireless far-field communication device of the data transmission module comprises at least one radio transmitter.

8. The kit according to claim 1, wherein the data reader module comprises at least one interface adapted to at least partially transfer the measurement data to an external device.

9. The kit according to claim 1, wherein the control device comprises a closed housing, wherein the sensor module mechanical interface comprises at least one protrusion formed on an outer side of the housing.

10. The kit according to claim 1, wherein the kit further comprises

f) an insertion device, the insertion device comprising at least one skin-penetration element adapted to perforate a skin of the user and to guide the sensor element into the body tissue of the user.

11. The kit according to claim 1, wherein the sensor module mechanical interface and the mechanical interface of the data reader module or the mechanical interface of the data transmission module are adapted to be connected by one of a form-fit connection and a force-fit connection.

12. The kit according to claim 1, wherein the sensor module mechanical interface and the mechanical interface of the data reader module or the mechanical interface of the data transmission module are adapted to be connected by a dovetail guide.

13. The kit according to claim 1, wherein the mechanical interface of the data reader module and the mechanical interface of the data transmission module each contain a slot inside a housing of the data reader module and the data transmission module, respectively, wherein the sensor module may at least partially be inserted into the slot.

14. The kit according to claim 1, wherein the sensor module is a disposable sensor module.

15. The kit according to claim 1, wherein the data reader module and the data transmission module are reusable units.

16. A method for determining a concentration of at least one analyte in a body fluid of a user, the method comprising a use of the kit according to claim 1, the method further comprising at least one step of reversibly coupling the data reader module to the sensor module and in transferring measurement data from the sensor module to the data reader module via wireless near-field communication, the method further comprising at least one step of reversibly coupling the data transmission module to the sensor module and transferring measurement data from the sensor module to the data transmission module via wireless near-field communication.

17. The method according to claim 16, the method further comprising at least one step of transferring measurement data from the data transmission module via wireless far-field communication to at least one external device.