Sensor insertion device and method for operating said device

• US 9,451,912 B2
• Filed: 09/23/2014
• Issued: 09/27/2016
• Est. Priority Date: 03/13/2012
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Matsumoto, Atsushi, Ohkoshi, Takahiro, Katsura, Hideki, Watanuki, Moriyuki
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US14/493,684
• Publication Number:
  US 20150051457A1
• Time in Patent Office: 735 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G01D 18/00 Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00
• CPC Class Codes: G01D 2218/10 Testing of sensors or measuring arrangements

Abstract

A sensor inserting device includes a device main body and a push handle for moving a detector of a sensor and an insertion needle, with the sensor held coupled to the insertion needle, into the body of a patient. A transmitter, for processing a signal from the sensor, is set in the device main body. A cable, allowing transmission of a signal between the sensor and the transmitter, is connected to the sensor (12) and the transmitter.

Claims

1. A method for determining the state of a sensor comprising:

a processor of a display unit receiving a first signal from a transmitter, in communication with the sensor, wherein the first signal is received before the sensor is inserted into a patient;

the processor retrieving a first threshold, wherein the first threshold is associated with a normal state for the sensor before the sensor is inserted into the patient;

the processor comparing the first signal to the first threshold to determine if the sensor is in the normal state;

if the first signal is not in the normal state, the processor;

determining that the sensor is not functioning properly; and

providing an alarm alerting that the sensor is not function properly

if the first signal is in the normal state, the processor determining that the sensor is functioning properly;

after insertion of the sensor;

receiving, by the processor, a second signal;

retrieving, by the processor, a second threshold, wherein the second threshold is associated with a second normal state for the sensor after the sensor has been inserted into the patient, and wherein the first threshold and the second threshold are different;

the processor comparing the second signal to the second threshold to determine if the sensor is in the second normal state;

if the second signal is not in the second normal state, the processor;

determining that the sensor is not functioning properly;

providing a second alarm alerting that the sensor is not function properly; and

if the second signal is in the second normal state, the processor determining that the sensor is functioning properly.

2. The method according to claim 1, wherein the first or second thresholds are predetermined and stored by the display unit in a memory.

3. The method according to claim 2, wherein the first and/or second thresholds are determined by previous measurements by the processor.

4. The method according to claim 3, wherein if the sensor is functioning properly after insertion, the patient measures an analyte with the sensor.

5. The method according to claim 4, wherein the alarm is one of a message displayed on the display unit, a vibration, or a blinking light.

6. The method according to claim 5, wherein after providing the alarm, the processor waits for the sensor to be one or more of replaced and reinserted.

7. The method according to claim 6, wherein the second signal is unstable for a period of time after insertion.

8. The method according to claim 7, wherein a signal characteristic of the first signal or second signal is compared to the first or second threshold, and wherein the signal characteristic is determined to go above the first or second threshold.

9. The method according to claim 8, wherein the signal characteristic is one or more of an amperage, a voltage, a rate of change over a predetermined amount of time, and/or an amount of change between two measurements.

10. A non-transitory computer readable medium having stored thereon computer executable instructions that, when executed by a processor, cause the processor to execute a method for determining the state of a sensor, the instructions comprising:

instructions to receive a first signal from a transmitter, in communication with the sensor, wherein the first signal is received before the sensor is inserted into a patient;

instructions to retrieve a first threshold, wherein the first threshold is associated with a normal state for the sensor before the sensor is inserted into the patient;

instructions to compare the first signal to the first threshold to determine if the sensor is in the normal state;

if the first signal is not in the normal state, instructions to;

determine that the sensor is not functioning properly;

provide an alarm alerting that the sensor is not function properly;

if the first signal is in the normal state, instructions to receive an indication that the sensor has been inserted into the patient;

instructions to receive a second signal from the sensor after the insertion;

instructions to retrieve a second threshold, wherein the second threshold is associated with a second normal state for the sensor after the sensor has been inserted into the patient, and wherein the first threshold and the second threshold are different;

instructions to compare the second signal to the second threshold to determine if the sensor is in the second normal state;

if the second signal is in the second normal state, instructions to determine that the sensor is functioning properly;

if the second signal is not in the second normal state, instructions to;

determine that the sensor is not functioning properly; and

provide a second alarm alerting that the sensor is not function properly.

11. The computer readable medium according to claim 10, wherein the first and second thresholds are predetermined and stored in a memory.

12. The computer readable medium according to claim 11, wherein if the sensor is functioning properly after insertion, instructions to receive a measurement of an analyte with the sensor.

13. The computer readable medium according to claim 12, wherein the alarm is one or more of a message displayed on the display unit, a vibration, and/or a blinking light.

14. The computer readable medium according to claim 13, wherein, after providing the alarm, instructions to wait for the sensor to be one or more of replaced and/or reinserted.

15. The computer readable medium according to claim 14, wherein a signal characteristic of the first signal or second signal is compared to the first or second threshold, and wherein the signal characteristic is one or more of an amperage, a voltage, a rate of change over a predetermined amount of time, and/or an amount of change between two measurements, and wherein the signal characteristic is determined to go above the first or second threshold.

16. A display unit comprising:

a memory;

a communications system;

a processor in communication with the memory and the communications system, wherein the processor;

executes a receiver module that;

receives a first signal from the communication system, wherein the first signal is sent from a transmitter, in communication with a sensor, wherein the first signal is received before the sensor is inserted into a patient;

receives a second signal from the communication system, wherein the second signal is sent from the transmitter, in communication with the sensor, wherein the second signal is received after the sensor is inserted into the patient;

executes a comparator module that;

retrieves a first threshold, from a threshold data store, wherein the first threshold is associated with a normal state for the sensor before the sensor is inserted into the patient;

compares the first signal to the first threshold to determine if the sensor is in the normal state;

if the first signal is not in the normal state, determine that the sensor is not functioning properly;

if the sensor is not functioning properly, sends an indication;

if the first signal is in the normal state and after the sensor has been inserted into the patient, retrieves a second threshold, from the threshold data store, wherein the second threshold is associated with a second normal state for the sensor after the sensor has been inserted into the patient, and wherein the first threshold and the second threshold are different;

compares the second signal to the second threshold to determine if the sensor is in the second normal state;

if the second signal is in the second normal state, determines that the sensor is again functioning properly;

if the second signal is not in the second normal state, determines that the sensor is not functioning properly;

if the sensor is not functioning properly, sends a second indication;

executes an alarm module that;

in response to receiving the indication, provides an alarm alerting a user that the sensor is not function properly; and

in response to receiving the second indication, provides a second alarm alerting a user that the sensor is not function properly.

17. The display unit according to claim 16, wherein the first threshold is one of calculated from past measurements of the first signal or predetermined.

18. The display unit according to claim 17, wherein, if the sensor is functioning properly, the processor indicates the sensor can be inserted by the patient to measure an analyte with the sensor.

19. The display unit according to claim 18, wherein the alarm is a readable message displayed on a display of the display unit.

20. The display unit according to claim 19, wherein a signal characteristic of the first signal or second signal is compared to the first threshold, and wherein the signal characteristic is one or more of an amperage, a voltage, a rate of change over a predetermined amount of time, and/or an amount of change between two measurements, and wherein the signal characteristic is determined to go above the first threshold.