RESPOSABLE BIOSENSOR ASSEMBLY AND METHOD

• US 20080161656A1
• Filed: 12/28/2007
• Published: 07/03/2008
• Est. Priority Date: 01/02/2007
• Status: Active Grant

• Current Assignee: Konamite Limited
• Original Assignee: Isense Corporation (Bayer AG)
• Inventors: Sass, Richard G., Ward, W. Kenneth, Bruce, Robert
• Granted Patent: US 8,845,530 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0285 Apparatus for single use
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

A device, system, and method for delivering a device such as a sensor or fluid transport structure or a fluid transport structure sensor combination into, for example, mammalian skin and receiving, analyzing, and displaying signals from the device such as a sensor are disclosed. A system in accordance with embodiments of the present invention includes a reusable sensor assembly including a transmitter, microcontroller, and housing plus disposable sensor assembly including a housing having an opening for receiving both the distal end of a biosensor, a sensor insertion guidance structure, and a transmission apparatus for transmitting signals received from the sensor to a reusable sensor assembly for transmission to an external electronic monitoring unit.

Claims

1. A reusable sensor assembly (RSA) comprising:

a RSA housing;

a transmitter disposed within the RSA housing; and

a microcontroller coupled to the transmitter, the microcontroller configured to be communicatively coupled to a disposable sensor assembly (DSA) having an analyte sensor, the microcontroller also configured to receive measurement signals from the DSA and to cause the transmitter to transmit telemetry signals in response to the received measurement signals.

2. The RSA of claim 1 further comprising a battery disposed within the RSA housing and configured to supply electrical power to the disposable sensor assembly.

3. The RSA of claim 1 further comprising a RSA electrical connector disposed within the RSA housing and coupled to the microcontroller, and wherein the RSA housing is configured to be removably secured to a DSA housing of the DSA in an orientation that facilitates a communicative coupling of the microcontroller to the DSA via the RSA electrical connector.

4. The RSA of claim 3 wherein the RSA electrical connector is configured to communicatively couple the microcontroller to the DSA via a direct electrical connection with a DSA electrical connector of the DSA or via inductive coupling with the DSA electrical connector.

5. The RSA of claim 1 wherein the RSA housing is configured to be removably secured to a DSA housing of the DSA in an orientation where at least a portion of a bottom surface of the RSA is flush against a top surface of the DSA housing, a bottom surface of the DSA housing adapted to be affixed to animal skin.

6. The RSA of claim 5 wherein the bottom surface of the RSA housing is configured to be tilted away from the top surface of the DSA housing while the RSA housing remains removably secured to the DSA housing.

7. The RSA of claim 5 wherein the bottom surface of the RSA housing comprises a cavity adapted to fit a docking socket disposed on the top surface of the DSA, the docking socket configured to be communicatively coupled to a RSA electrical connector disposed within the RSA when the RSA housing is removably secured to the DSA housing.

8. The RSA of claim 1 wherein the measurement signals originate from the analyte sensor and the telemetry signals include the measurement signals.

9. The RSA of claim 1 wherein the RSA housing is adapted to be removably secured to the DSA housing to form a resposable sensor assembly, adapted to be removed from the DSA housing, and removably secured to another DSA housing to form another resposable sensor assembly.

10. A disposable sensor assembly (DSA) comprising:

a DSA housing having an opening;

a sensor insertion guidance structure disposed within the housing and adapted to provide axial support to an analyte sensor and to allow the analyte sensor to at least partially pass through the guidance structure and out the opening upon application of motive force to the analyte sensor thereby placing the analyte sensor into an inserted position; and

a coupling device positioned on or in the sensor insertion guidance structure and adapted to facilitate a communicative coupling of the analyte sensor to a microcontroller of a reusable sensor assembly (RSA) while the analyte sensor is in the inserted position, the analyte sensor configured to generate measurement signals while partially inserted into animal skin.

11. The DSA of claim 10 wherein the DSA housing is adapted to be removably secured to a RSA housing of the RSA and the positioning of the coupling device on or in the sensor insertion guidance structure is adapted to facilitate the communicative coupling of the analyte sensor to the microcontroller while the DSA is removably secured to a RSA housing of the RSA.

12. The DSA of claim 11 wherein the coupling device is a DSA electrical connector adapted to be communicatively coupled to a RSA electrical connector disposed within the RSA housing.

13. The DSA of claim 12 wherein the DSA electrical connector is part of a docking socket disposed on a top surface of the DSA housing, the docking socket adapted to fit into a cavity disposed on a bottom surface of the RSA housing when the DSA housing is removably secured to the RSA housing, the cavity including the RSA electric connector.

14. The DSA of claim 12 wherein the DSA is adapted to receive electrical power from a battery of the RSA via the DSA electrical connector.

15. The DSA of claim 10 further comprising a signal transmission apparatus configured to communicate with the microcontroller via a RSA signal transmission apparatus via infrared, direct electrical connection, a personal area network (PAN) transmission, or inductive coupling.

16. The DSA of claim 10 further comprising a docking socket disposed on a top surface of the DSA housing, the sensor insertion guidance structure extending into the docking socket.

17. The DSA of claim 16 wherein the docking socket is configured to accept a removable sensor cartridge having the analyte sensor disposed within a cartridge guidance structure of the removable sensor cartridge, the sensor cartridge adapted to accept an inserter device containing an actuator configured to apply the motive force onto a distal end of the analyte sensor.

18. The DSA of claim 17 wherein the inserter is configured to extract the removable sensor cartridge from the docking socket after sensor insertion.

19. The DSA of claim 10 further comprising a user-activated actuator disposed within the DSA housing and configured to apply the motive force onto a distal end of the analyte sensor.

20. The DSA of claim 10 further comprising an adhesive patch disposed on an outside surface of the DSA housing and adapted to be adhered to animal skin.

21. A method comprising:

attaching, by a user, a resposable sensor assembly to a skin surface of a patient, the resposable sensor assembly comprising a reusable sensor assembly (RSA) and a disposable sensor assembly (DSA), the RSA comprising a RSA housing, a transmitter disposed in or on the RSA housing, and a microcontroller disposed within the RSA housing, coupled to the transmitter, and configured to receive measurement signals from an analyte sensor disposed within a DSA housing of the DSA, the microcontroller also configured to cause the transmitter to transmit telemetry signals in response to the received measurement signals;

activating, by the user, an actuator to insert the analyte sensor partially into the skin surface; and

after a period of time, removing, by the user, the resposable sensor assembly from the skin surface including the analyte sensor, separating the RSA from the DSA, and attaching the RSA to another DSA to form another resposable sensor assembly.

22. The method of claim 21 further comprising attaching, by the user, the another resposable sensor assembly to either the skin surface, a different skin surface of the patient, or to a skin surface of another patient.

23. The method of claim 21 wherein the RSA housing is adapted to be tilted upwards to expose a top surface of the DSA, the method further comprising:

fitting an inserter device onto a sensor cartridge covering a docking socket disposed on the top surface of the DSA, the inserter device containing the actuator, the sensor cartridge containing the analyte sensor;

removing the inserter device by the user upon activating the actuator, the removing of the inserter device causing an extraction of the sensor cartridge and an exposing of the docking socket; and

tilting, by the user, the RSA housing downward so that it covers the docking socket in a way that forms a communicative coupling between the docking socket and the microcontroller of the RSA.

24. A resposable sensor assembly comprising:

a reusable sensor assembly (RSA) including;

a RSA housing;

a transmitter disposed within the RSA housing;

a microcontroller coupled to the transmitter and configured to receive measurement signals from a disposable sensor assembly (DSA) and to cause the transmitter to transmit telemetry signals in response to the measurement signals; and

the DSA including;

a DSA housing having an opening;

a sensor insertion guidance structure disposed within the housing, and adapted to provide axial support to the analyte sensor and to allow the analyte sensor to at least partially pass through the guidance structure and out the opening upon application of motive force to the analyte sensor thereby placing the analyte sensor into an inserted position; and

a coupling device positioned on or in the sensor insertion guidance structure and adapted to facilitate a communicative coupling of the analyte sensor to the microcontroller while the analyte sensor is in the inserted position.

25. The resposable sensor assembly of claim 24 wherein the RSA housing is configured to be removably secured to the DSA housing and the coupling device is positioned and adapted to facilitate the communicative coupling of the analyte sensor to the microcontroller while the RSA housing is removably secured to the DSA housing.