DEPLOYMENT SYSTEM AND METHOD FOR OPTICAL ANALYTE SENSOR

• US 20110263953A1
• Filed: 04/27/2011
• Published: 10/27/2011
• Est. Priority Date: 04/27/2010
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: GluMetrics, Inc.
• Inventors: Chesnin, Kenneth J., Gamsey, Soya, Markle, David R.
• Application Number:
  US13/095,748
• Publication Number:
  US 20110263953A1
• Time in Patent Office: Days
• US Class Current: 600/310
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/06 Accessories for medical measuring apparatus
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1491 Heated applicators
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

Embodiments of the invention are directed to a delivery device and method for deploying an optical analyte sensor. The delivery device comprises hollow tubes configured to operate telescopically. The optical sensor is configured to retract and extend from a distal end of the delivery device, by sliding the telescoping tubes with respect to one another. The delivery device may also have a locking mechanism such that the distal end portion of the sensor will extend to a preset locked position beyond the delivery device, e.g., during calibration and deployment. The device is capable of being used to ship, calibrate, and deploy the sensor while maintaining sterility and avoiding exposure to the external environment.

Claims

1. An analyte detection system, comprising:

an optical fiber sensor comprising a proximal end portion and a distal end portion, wherein a chemical indicator system is disposed along the distal end portion, the chemical indicator system comprising a fluorophore and an analyte binding moiety, which interact to generate a fluorescent signal related to an amount of analyte bound to the analyte binding moiety; and

a deployment device comprising

telescoping tubes configured to extend and retract at least the distal end portion of the optical fiber sensor, such that sensor integrity, hydration and sterility is maintained during sensor calibration and deployment;

a latch disposed on the telescoping tubes and configured to engage with a base disposed on the telescoping tubes, such that when the latch is engaged with the base the distal end portion of the optical fiber sensor extends by a predetermined length; and

an electrical/optical connector disposed at a proximal end of the deployment device and configured to electrically and optically connect with a cable configured to transmit electrical signals and optical signals to and from a monitor apparatus;

wherein the optical fiber sensor is housed concentrically in the telescoping tubes.

2. The analyte detection system of claim 1, wherein the base comprises a gasket configured to create a static seal between the optical fiber sensor and the gasket when the latch and base are engaged.

3. The analyte detection system of claim 2, wherein the gasket is configured to maintain a dynamic seal between the gasket and optical fiber sensor when the latch and base are engaged or opened, wherein the static seal is stronger than the dynamic seal.

4. The analyte detection system of claim 1, further comprising a heating element configured to heat a portion of at least one telescoping tube, wherein the portion of the at least one telescoping tube is configured to house a calibration buffer to calibrate the chemical indicator system.

5. The analyte detection system of claim 4, wherein the heating element comprises a heating tape.

6. The analyte detection system of claim 1, wherein the cable comprises electrical wires configured to transmit the electrical signal and optic fibers configured to transmit the optical signals, wherein the optic signals comprises:

a first plurality of optic fibers configured to transmit a first excitation signal from a first emitter;

a second plurality of optic fibers configured to transmit a second excitation signal from a second emitter;

a third plurality of optic fibers configured to transmit a first fluorescent signal from the chemical indicator system; and

a fourth plurality of optic fibers configured to transmit a second fluorescent signal from the chemical indicator signal.

7. The analyte detection system of claim 6, wherein

the first plurality of optic fibers comprises about two fibers;

the second plurality of optic fibers comprises about three fibers;

the third plurality of optic fibers comprises about twelve fibers; and

the fourth plurality of optic fibers comprises about two fibers.

8. The analyte detection system of claim 1, wherein the electrical/optical connector comprises a housing configured to couple with a monitor connector such that the optical signals between the electrical/optical connector and the cable are stable, the housing comprising one or more optical ferrule coupled with a split sleeve and with a ferrule capture element.

9. The analyte detection system of claim 1, wherein the base further comprises a lock and a key configured to open and close the lock, wherein the key is detachable from the base.

10. The analyte detection system of claim 1, wherein the base comprises a clip, wherein the base position is adjustable along the telescoping tube, wherein the clip comprises a button to allow or disallow an adjustment in the base position.

11. A method of detecting an analyte concentration in a blood vessel, comprising:

introducing a cannula into the blood vessel;

connecting a distal end of a deployment device to the cannula, wherein the deployment device comprises telescoping tubes configured to extend and retract at least a distal end portion of an analyte sensor;

deploying the analyte sensor through the cannula and into the blood vessel by sliding the telescoping tubes with respect to one another; and

measuring the analyte concentration by detecting a signal related to the analyte concentration.

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

connecting a calibration buffer injector to the distal end of the deployment device;

injecting a calibration buffer into the deployment device, wherein the distal end portion of the analyte sensor is submerged in the calibration buffer;

heating the calibration buffer to a predetermined temperature with a heating element;

calibrating the analyte sensor; and

removing the calibration buffer from the deployment device.

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

connecting the distal end of the deployment device to a calibration vessel;

extending the distal end portion of the analyte sensor into the calibration vessel by sliding the telescoping tubes with respect to one another;

heating the calibration buffer to a predetermined temperature with a heating element;

calibrating the analyte sensor; and

retracting the distal end portion of the analyte sensor back into the deployment device by sliding the telescoping tubes with respect to one another.

14. The method according to claim 12 or 13, wherein the heating element comprises a heating tape.

15. The method according to claim 11, wherein prior to connecting the distal end of the deployment device to the cannula, the method further comprises:

calibrating the analyte sensor at a predetermined calibration temperature.

16. The method according to claim 11, wherein the deployment device further comprises a catch assembly disposed along the telescoping tubes, the catch assembly being configured to lock the telescoping tubes in a preset position relative to one another, wherein the analyte sensor is extended beyond the distal end of the deployment device when the catch assembly is locked, and wherein the step of deploying the analyte sensor further comprises sliding the telescoping tubes with respect to one another until the catch assembly is locked.

17. The method according to claim 11, further comprising flushing the analyte sensor with a flushing solution.

18. The method according to claim 11, further comprising delivering therapeutic agents.

19. An analyte sensor deployment kit, comprising:

an analyte sensor with proximal and distal end regions, comprising;

an optical fiber with proximal and distal ends;

a chemical indicator system, optically coupled to the optical fiber and disposed along the distal end region of the analyte sensor, the chemical indicator system being capable of generating an emission light signal related to the analyte concentration upon interrogation with an excitation light signal;

a thermocouple disposed along the distal end region of the analyte sensor and comprising a wire that extends proximally along the optical fiber; and

a sensor connector located at the proximal end region of the analyte sensor and coupled to the proximal end of the optical fiber and the thermocouple wire; and

a deployment system, comprising;

a first hollow tube comprising a distal end and a proximal end;

a second hollow tube, slidably and coaxially engaged with the first hollow tube, the second hollow tube comprising a distal end and a proximal end;

a third hollow tube, slidably and coaxially engaged with the second hollow tube, the third hollow tube comprising a distal end and a proximal end;

a connector located at the distal end of the third hollow tube and configured to connect to a first external device; and

a multi-connector junction located at the proximal end of the third hollow tube, configured connect to a second external device;

wherein the analyte sensor is slidably and coaxially engaged within the first, second and third hollow tubes of the deployment system.

20. The analyte sensor deployment kit of claim 19, wherein the first external device is selected from the group consisting of a calibration chamber, a storage chamber, and a cannula.

21. The analyte sensor deployment kit of claim 19, wherein the first external device comprises a calibration chamber comprising a heating element coupled to a monitor configured to control the heating element.

22. The analyte sensor deployment kit of claim 19, wherein the second external device comprises a fluid delivery device.

23. The analyte sensor deployment kit of claim 19, wherein:

the second external device comprises a pressure sensor configured to detect the pressure inside the third tube and to generate a value indicative of a pressure level; and

a pressure control module configured to adjust the pressure inside the third tube depending on the pressure level relative to a predetermined threshold.

24. The analyte sensor deployment kit of claim 19, wherein the second external device comprises a feedback system, comprising:

a blood extracting module configured to extract blood from the patient;

a blood analyte measuring module;

a comparison module configured to compare the analyte concentration measured by the chemical indicator system of the analyte sensor to an analyte concentration measured by the blood analyte measuring module.

25. The analyte sensor deployment kit of claim 19, further comprising a memory device configured to store operational information.