SENSOR WITH OPTICAL INTERFACE

• US 20150119662A1
• Filed: 10/13/2014
• Published: 04/30/2015
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Larson, Eric Allan, Aasmul, Soren, Lebron, Voltaire Isaac, Holz, Kevin, Rodriguez, Jasson, Kantak, Ameya
• Granted Patent: US 9,936,905 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• 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 2562/16 Details of sensor housings or probes; Details of structural supports for sensors A61B2560/0462 takes precedence
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G02B 6/32 having lens focusing means positioned between opposed fibre ends with lens being an integral part of the single fibre end G02B6/262
• CPC Class Codes: G02B 6/4292 the light guide being disconnectable from the opto-electronic element, e.g. mutually self aligning arrangements

Abstract

A device for detection or measurement of a carbohydrate analyte in fluid comprises:

• • an optical sensor comprising components of an assay for carbohydrate analyte, the readout of which is a detectable or measurable optical signal, and a light guide having a distal portion optically coupled to the assay components and a proximal portion; and
  • a reader for interrogating the optical sensor, the reader comprising an assay interrogating system including a lens; and
  • an interface portion forming part of at least one of the optical sensor and the reader, the interface portion being capable of removably constraining the proximal portion of the light guide and the lens of the assay interrogating system in an optically coupled arrangement.

The device may be combined with an insulin-infusion system.

Claims

1. A device for the detection or measurement of a carbohydrate analyte in fluid comprising:

an optical sensor comprising components of an assay for carbohydrate analyte, the readout of which is a detectable or measurable optical signal, and a light guide having a distal portion optically coupled to the assay components and a proximal portion; and

a reader for interrogating the optical sensor, the reader comprising an assay interrogating system including a lens; and

an interface portion forming part of at least one of the optical sensor and the reader, the interface portion being capable of removably constraining the proximal portion of the light guide and the lens of the assay interrogating system in an optically coupled arrangement.

2. A device as claimed in claim 1, wherein in use the proximal portion of the light guide is disposed externally to a body of a user and the distal portion of the light guide and the assay components are placed internally in the user'"'"'s body.

3. A device as claimed in claim 1, wherein when the proximal portion of the light guide and the lens are constrained in the optically coupled arrangement, the proximal portion of the light guide is within the focal plane tolerance and optical axis tolerance of the lens.

4. A device as claimed in claim 1, wherein when the proximal portion of the light guide and the lens are constrained in the optically coupled arrangement, an optical axis of the lens is parallel to an optical axis of the light guide as measured at the proximal portion of the light guide.

5. A device as claimed in claim 1, wherein when the proximal portion of the light guide and the lens are constrained in the optically coupled arrangement, the interface portion constrains the relative position of the light guide and lens in directions perpendicular to an optical axis of the lens.

6. A device as claimed in claim 1, wherein when the proximal portion of the light guide and the lens are constrained in the optically coupled arrangement, the relative position of the light guide and lens is constrained within a tolerance range of less than or equal to ±

50 μ

m in directions perpendicular to an optical axis of the lens.

7. A device as claimed in claim 1, further comprising a detachable connection between the optical sensor and the reader, the detachable connection being capable of further constraining the proximal portion of the light guide and the lens of the assay interrogating system within the optically coupled arrangement.

9. A device as claimed in claim 1, wherein when the proximal portion of the light guide and the lens are constrained in the optically coupled arrangement, the relative position of the light guide and lens is constrained within a tolerance range of less than or equal to ±

200 μ

m in a direction parallel to an optical axis of the lens.

10. A device as claimed in claim 9, wherein when the proximal portion of the light guide and the lens are constrained in the optically coupled arrangement, the relative position of the light guide and lens is constrained within a tolerance range of less than or equal to ±

100 μ

m in the direction parallel to the optical axis of the lens.

11. A device as claimed in claim 1, wherein the interface portion is a light guide interface portion forming part of the reader.

12. A device as claimed in claim 11, wherein the light guide interface portion of the reader comprises a flared opening adapted to receive the proximal portion of the light guide.

13. A device as claimed in claim 12, wherein the flared opening has a surface of Roughness Average 0.8 to 1.6 μ

m over a distance of 100 μ

m.

14. A device as claimed in claim 12, wherein the flared opening comprises a single chamfer.

15. A device as claimed in claim 12, wherein the flared opening of the light guide interface portion of the reader is frusto-conical in shape.

16. A device as claimed in claim 12, wherein the flared opening of the light guide interface portion terminates in a channel adapted to accommodate the proximal portion of the light guide.

17. A device as claimed in claim 11, wherein the lens is mounted to the light guide interface portion of the reader.

18. A device as claimed in claim 17, wherein the lens is held in place by a lens-retaining insert.

19. A device as claimed in claim 18, wherein the lens-retaining insert is held in position by one or more arrangements selected from the group consisting of a screw thread arrangement, a friction fit arrangement, a resilient arrangement and an adhesive arrangement.

20. A device as claimed in claim 1, wherein the light guide comprises one or more optical fibers.

21. A device as claimed in claim 1, wherein the light guide has at least one cross-sectional dimension in the range of 50 μ

m to 600 μ

m.

22. A device as claimed in claim 7, wherein the detachable connection between the optical sensor and the reader comprises a projecting portion of the optical sensor and a bore of the reader, the projecting portion being capable of engaging the bore.

23. A device as claimed in claim 7, wherein the detachable connection between the optical sensor and the reader comprises moveable fasteners on at least one of the optical sensor and the reader.

24. A device as claimed in claim 7, further comprising a locking component capable of inhibiting relative movement between the optical sensor and the reader.

25. A device as claimed in claim 7, further comprising an anti-rotation arrangement capable of inhibiting relative rotation of the optical sensor and reader in the optically coupled arrangement.

26. A device as claimed in claim 1, wherein the assay interrogating system is a stacked planar integrated optical system (SPIOS).

27. A device as claimed in claim 1, wherein the assay interrogating system includes an illumination source.

28. A device as claimed in claim 27, wherein said illumination source is a red laser diode.

29. A device as claimed in claim 1, wherein the components of the assay are retained in an assay compartment defined by the distal portion of the light guide and a material that permits diffusion of the analyte but not the assay components.

30. A device as claimed in claim 1, wherein the components of the assay include an analyte binding molecule labelled with one of a proximity based signal generating/modulating moiety pair;

and

an analyte analog capable of competing with the analyte for binding to the analyte binding molecule labelled with the other of the proximity based signal generating/modulating moiety pair.

31. A device as claimed in claim 30, wherein the analyte binding molecule comprises mannose binding lectin labelled with one of the proximity based signal generating/modulating moiety pair and the analyte analog comprises dextran labelled with the other of the proximity based signal generating/modulating moiety pair.

32. A device as claimed in claim 30, wherein one of the proximity based signal generating/modulating moiety pair is selected from Alexa Fluor 647 (AF647), Alexa Fluor 750 (AF750), and QSY 21.

33. A device as claimed in claim 30, wherein one of the proximity based signal generating/modulating moiety pair is hexamethoxy crystal violet-1 (HMCV-1).

34. A device as claimed in claim 30, wherein the assay components further comprise a reference fluorophore.

35. A device as claimed in claim 34, wherein said reference fluorophore is Alexa Fluor 700 (AF700).

36. A device as claimed in claim 1, wherein the analyte is glucose.

37. A device as claimed in claim 1, further comprising a non-optical analyte sensor.

38. A device as claimed in claim 37, wherein the non-optical analyte sensor is an electrochemical sensor.

39. A device as claimed in claim 1, wherein the reader further comprises a transmitter for transmitting detected or measured analyte data.

40. A system comprising a device as claimed in claim 1 and a monitor displaying analyte data.

41. A system comprising a device as claimed in claim 1 and an insulin-infusion system.

42. A reader for use in a device as claimed in claim 1, comprising an assay interrogating system including a lens;

and a light guide interface portion comprising a flared opening adapted to receive a proximal portion of a light guide.

43. A method of detecting or measuring a carbohydrate analyte using a device as claimed in claim 1, comprising detecting or measuring the optical signal readout of the assay components via the light guide using the assay interrogating system of the reader.

44. A method of detecting or measuring a carbohydrate analyte as claimed in claim 43, further comprising initial implantation of the assay components and distal portion of the light guide into the body of a user.

45. A method of detecting or measuring a carbohydrate analyte as claimed in claim 43, further comprising a step of optically coupling the proximal portion of the light guide to the lens of the assay interrogating system via the interface portion.

8. A device as claimed in claim 8, wherein when the proximal portion of the light guide and the lens are constrained in the optically coupled arrangement, the detachable connection constrains the relative position of the light guide and lens in directions parallel to an optical axis of the lens.