Optical sensor configuration for ratiometric correction of blood glucose measurement

• US 8,467,843 B2
• Filed: 11/04/2009
• Issued: 06/18/2013
• Est. Priority Date: 11/04/2009
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: GluMetrics, Inc.
• Inventors: Markle, David R., Gamsey, Soya, Peyser, Thomas A.
• Primary Examiner(s): BLACKMAN, ROCHELLE ANN J
• Application Number:
  US12/612,602
• Publication Number:
  US 20110105866A1
• Time in Patent Office: 1,322 Days
• Field of Search: 600/316, 600/309, 600/317, 600/337, 600/365, 600/364, 600/366
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 2562/043 in a linear array
• 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 5/14735 comprising an immobilised reagent
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B

Abstract

Embodiments of the invention are directed to an optical sensor for detecting blood glucose. The sensor comprises a chemical indicator system disposed within a gap between the distal end of an optical fiber and an atraumatic tip portion, wherein the optical fiber and atraumatic tip portion are coupled by a coupling member, such as a rod or hypotube or cage that traverses the gap. The sensor further comprises a means for generating and detecting an optical reference signal unrelated to the blood glucose, such that ratiometric correction of blood glucose measurements for artifacts in the optical system is enabled.

Claims

1. A sensor for detecting an analyte concentration in a blood vessel, comprising:

an optical fiber with proximal and distal ends;

an atraumatic tip portion with proximal and distal ends, wherein the proximal end of the atraumatic tip portion is separated from the distal end of the optical fiber, such that a gap exists between the atraumatic tip portion and the optical fiber;

a rod with proximal and distal ends, wherein the proximal end of the rod is attached to the distal end of the optical fiber, and wherein the distal end of the rod is attached to the proximal end of the atraumatic tip portion, such that the rod traverses the gap and couples the optical fiber to the atraumatic tip portion;

a chemical indicator system disposed within the gap and capable of generating an emission light signal in response to an excitation light signal, wherein the intensity of the emission light signal is related to the analyte concentration; and

a selectively permeable membrane disposed over the gap, wherein the sensor is sized for deployment within the blood vessel.

2. The sensor of claim 1, wherein the chemical indicator system is further immobilized within the gap by a hydrogel.

3. The sensor of claim 1, further comprising a temperature sensor.

4. The sensor of claim 1, wherein the optical fiber has a diameter of between about 0.005 inches and about 0.020 inches.

5. The sensor of claim 1, further comprising a reflective region.

6. The sensor of claim 5, wherein the reflective region comprises a reflective surface of the proximal end of the rod.

7. The sensor of claim 1, wherein the rod is attached to the optical fiber by heating.

8. The sensor of claim 1, wherein the rod is attached to the optical fiber by a reflective adhesive.

9. The sensor of claim 8, wherein the shape of the distal end of the atraumatic tip portion is configured to reduce trauma within the blood vessel and selected from the group consisting of hemispherical, parabolic, and elliptical.

10. The sensor of claim 1, wherein the distal end of the atraumatic tip portion is flexible.

11. The sensor of claim 1, wherein the distal end of the atraumatic tip portion is deformable.

12. The sensor of claim 1, wherein the distal end of the atraumatic tip portion is formed from at least one material selected from the group consisting of plastics, polymers, gels, metals and composites.

13. The sensor of claim 1, wherein the rod is formed from at least one material selected from the group consisting of metal, metal alloy, plastic, polymer, ceramic, and composite material.

14. The sensor of claim 13, wherein the rod is formed from stainless steel, titanium, or Nitinol.

15. The sensor of claim 1, wherein the rod is cylindrical.

16. The sensor of claim 15, wherein the rod diameter is between about 0.002 inches and about 0.010 inches.

17. The sensor of claim 1, wherein the rod is flexible.

18. The sensor of claim 1, wherein the rod is stiffer than the optical fiber.

19. The sensor of claim 1, wherein the rod is sufficiently stiff to prevent flexing of the sensor along the gap.

20. A sensor for detecting an analyte concentration in a blood vessel, comprising:

an optical fiber with proximal and distal ends;

an atraumatic tip portion with proximal and distal ends, wherein the proximal end of the atraumatic tip portion is separated from the distal end of the optical fiber, such that a gap exists between the atraumatic tip portion and the optical fiber;

a hypotube with proximal and distal ends, wherein the proximal end of the hypotube is attached to the distal end of the optical fiber, and wherein the distal end of the hypotube is attached to the proximal end of the atraumatic tip portion, such that the hypotube traverses the gap and couples the optical fiber to the atraumatic tip portion, wherein the hypotube comprises at least one window that opens onto the gap;

a chemical indicator system disposed within the gap and capable of generating an emission light signal in response to an excitation light signal, wherein the intensity of the emission light signal is related to the analyte concentration; and

a selectively permeable membrane disposed over the at least one window, wherein the sensor is sized for deployment within the blood vessel.

21. The sensor of claim 20, wherein the chemical indicator system is further immobilized within the gap by a hydrogel.

22. A sensor for detecting an analyte concentration in a blood vessel, comprising:

an optical fiber with proximal and distal ends;

an atraumatic tip portion with proximal and distal ends, wherein the proximal end of the atraumatic tip portion is separated from the distal end of the optical fiber, such that a gap exists between the atraumatic tip portion and the optical fiber;

a cage connecting the optical fiber and atraumatic tip portion, wherein the optical fiber is at least partially enclosed within the cage, and wherein the cage has at least one window;

a chemical indicator system disposed within the cage, wherein the chemical indicator system is adjacent the window and is separated from analyte by a selectively permeable membrane, and wherein the chemical indicator system is capable of generating an emission light signal in response to an excitation light signal, wherein the intensity of the emission light signal is related to the analyte concentration; and

a reference material, wherein the reference material is configured to either reflect a portion of the excitation light signal before the excitation light signal enters the chemical indicator system or to return a second emission light signal, wherein the intensity of the second emission light signal is not related to the analyte concentration.

23. A sensor for detecting an analyte concentration in a blood vessel, comprising:

an optical fiber with a proximal end and a distal end, wherein the distal end of the optical fiber comprises a glucose sensing hydrogel and wherein the glucose sensing hydrogel comprises a first fluorophore, a quencher, and at least one glucose binding moiety;

a reference fiber adjacent the optical fiber having a proximal end and a distal end, wherein the distal end of the reference fiber comprises a reference material, wherein the reference material comprises a second fluorophore;

a light emitting diode operably coupled to the glucose fiber and the reference fiber, wherein the light emitting diode sends an excitation light to the glucose fiber and the reference fiber;

a glucose signal detector operatively coupled to the glucose fiber, wherein the glucose signal detector receives a first fluorescent light from the glucose fiber; and

a reference signal detector operatively coupled to the reference fiber, wherein the reference signal detector receives a second fluorescent light from the reference fiber.

24. The sensor of claim 23, wherein the first fluorophore is the same as the second fluorophore.

25. The sensor of claim 23, wherein the first fluorophore is different than the second fluorophore.

26. The sensor of claim 23, wherein the reference material comprises a quencher.

27. The sensor of claim 23, wherein the reference material is encased in a glucose impermeable membrane.