Sensor insertion device and method for operating said device

• US 9,393,043 B2
• Filed: 09/12/2014
• Issued: 07/19/2016
• 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:
  US14/485,148
• Publication Number:
  US 20150073238A1
• Time in Patent Office: 676 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• 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

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 sensor inserting device comprising:

a device main body comprises a signal transmitting part;

a movement mechanism provided in the device main body and configured to move a detector of a sensor and an insertion needle, while in a held state, the sensor is held together with the insertion needle for piercing a body of a person to be measured, wherein the sensor is electrically connected to the signal transmitting part; and

a signal processor configured to be attached to and detached from the device main body and electrically connected to the signal transmitting part, wherein a signal, associated with biological information, produced by the sensor is transmitted through the signal transmitting part to the signal processor, and wherein the signal transmitting part transmits a signal between the sensor and the signal processor when the signal processor is attached to the device main body in the held state of the movement mechanism, wherein the signal transmitting part is a flexible cable that electrically connects the sensor to the signal processor when in the held state, moves with the sensor during sensor insertion, and maintains the electrical connection while the sensor is indwelling.

2. The sensor inserting device according to claim 1, further comprising:

an alarming unit operable to determine an operating state of the sensor when the signal processor is attached and operable to inform a user of the fault in the sensor when a circuit, including one or more of a group comprising the signal transmitting part connected to the sensor and the sensor, has a fault.

3. The sensor inserting device according to claim 1, wherein the device main body includes an indwelling member placed on a skin of the person with both the sensor and the signal processor, the indwelling member comprising:

a signal processor attaching unit attaching the signal processor; and

a fix-connection unit fixing one of two ends of the signal transmitting part to electrically connect the signal processor and the signal transmitting part when the signal processor is attached.

4. The sensor inserting device according to claim 3, wherein a first distance from the sensor to the fix-connection unit when the sensor is in the held state and a second distance from the sensor to the fix-connection unit when the detector is inserted in the body of the person to be measured are approximately same.

5. The sensor inserting device according to claim 3, wherein the indwelling member comprises a receiving portion for receiving the signal transmitting part at a location in a vicinity of where the detector is inserted into the person to be measured.

6. The sensor inserting device according to claim 1, wherein the movement mechanism is a push handle that is contained in the device main body and configured to advance toward the person to be measured to insert the detector and the insertion needle and to retreat away from the person to be measured to pull out the insertion needle, and wherein the device main body and the push handle are provided with a retreat preventing mechanism configured to prevent the push handle from retreating at a distanced position in which the insertion needle is separated from the person to be measured.

7. The sensor inserting device according to claim 6, wherein the device main body and the push handle are provided with an advance preventing mechanism to prevent the push handle from inadvertently advancing from the distanced position.

8. The sensor inserting device according to claim 7, wherein the advance preventing mechanism comprises:

a distal end portion of an elastic piece provided on the push handle; and

an engagement portion provided at a proximal end of the device main body, the distal end portion of the elastic piece projecting from a proximal end of the device main body at the distanced position to engage with the engagement portion thereby preventing the push handle from advancing.

9. The sensor inserting device according to claim 1, wherein the movement mechanism is a push handle contained in the device main body and configured to advance toward the person to be measured to insert the detector and the insertion needle and to retreat away from the person to be measured to pull out the insertion needle, wherein the device main body and the push handle are provided with a retaining mechanism configured to retain the push handle at a retaining position in which the push handle in the held state is retained to be separated from a distal end portion of the device main body, and wherein the retaining mechanism allows the push handle to advance by operating a controller provided on the push handle.

10. A method for inserting a sensor with a sensor inserting device that holds the sensor and an insertion needle for measuring biological information at a location distanced from a distal end portion of a device main body by a predetermined distance, the method comprising:

providing the sensor inserting device, the sensor inserting device comprising;

the sensor;

a fix-connection unit;

a signal transmitting part, disposed between the sensor and the fix-connection unit of the device main body, for transmitting a signal including biological information output from the sensor;

connecting a signal processor, for processing the signal, to the device main body, wherein the signal processor is electrically connected to the fix-connection unit to allow transmission of the signal between the sensor and the signal processor, wherein the signal transmitting part is a flexible cable that electrically connects the sensor to the signal processor when in the held state, moves with the sensor during sensor insertion, and maintains the electrical connection while the sensor is indwelling;

advancing the sensor and the insertion needle toward a distal end by a movement mechanism provided in the device main body to project the detector of the sensor and a portion of the insertion needle to a distal end of the device main body and into the person; and

removing the insertion needle from the sensor by retreating the insertion needle toward a proximal end by the movement mechanism while leaving the detector in the person.

11. The method according to claim 10, further comprising:

detecting an operating state of the sensor, between the connecting step and the advancing step; and

informing the user of an abnormality of the sensor, by an alarming unit, if there is an abnormality in a circuit, including one or more of a group comprising the signal transmitting part connected to the sensor and the sensor.

12. The method according to claim 10, further comprising:

detecting an operating state of the sensor, after the removing step; and

informing the user of an abnormality of the sensor, by an alarming unit, if there is an abnormality in a circuit, including one or more of a group comprising the signal transmitting part connected to the sensor and the sensor.

13. The method according to claim 12, wherein the detecting is conducted before a stable signal is received from the sensor.

14. An analyte sensing system comprising:

a sensor inserting device comprising;

a device main body comprising a signal transmitting part;

a movement mechanism provided in the device main body and configured to move a detector of a sensor and an insertion needle, while in a held state, the sensor is held together with the insertion needle for piercing a body of a person to be measured, wherein the sensor is electrically connected to the signal transmitting part; and

a signal processor configured to be attached to and detached from the device main body and electrically connected to the signal transmitting part, wherein a signal, associated with biological information, produced by the sensor is transmitted through the signal transmitting part to the signal processor, and wherein the signal transmitting part that transmits a signal between the sensor and the signal processor when the signal processor is attached to the device main body in the held state of the movement mechanism, wherein the signal transmitting part is a flexible cable that electrically connects the sensor to the signal processor when in the held state, moves with the sensor during sensor insertion, and maintains the electrical connection continuously while the sensor is in the held state, while the sensor is inserted, while an insertion needles is withdrawn, and while the sensor indwelling; and

an alarming unit in communication with the sensor inserting device, the alarming unit operable to determine an operating state of the sensor when the signal processor is attached and operable to inform a user of the fault in the sensor when a circuit, including one or more of a group comprising the signal transmitting part connected to the sensor and the sensor, has a fault.

15. The analyte sensing system according to claim 14, wherein the alarming unit is operable to determine a first operating state of the sensor before the sensor is inserted into the person.

16. The analyte sensing system according to claim 15, wherein the alarming unit is operable to compare a first signal from the sensor to a first threshold during the first operating state.

17. The analyte sensing system according to claim 16, wherein, if the first signal is below the first threshold during the first operating state, the alarming unit is operable to provide an alert to the user that the fault in the sensor has occurred.

18. The analyte sensing system according to claim 14, wherein the alarming unit is operable to determine a second operating state of the sensor after the sensor is inserted into the person but before the sensor provides a stable signal.

19. The analyte sensing system according to claim 18, wherein the alarming unit is operable to compare a second signal from the sensor to a second threshold during the second operating state.

20. The analyte sensing system according to claim 19, wherein, if the second signal is below the second threshold during the second operating state, the alarming unit is operable to provide an alert to the user that the fault in the sensor has occurred.