Hypodermic Optical Monitoring of Bodily Analyte

• US 20100249558A1
• Filed: 11/20/2008
• Published: 09/30/2010
• Est. Priority Date: 11/21/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Kaidar, Ruthy, Gescheit, Iddo M., Yodfat, Ofer, Gescheit, Illai
• Granted Patent: US 8,615,281 B2
• Time in Patent Office: Days
• US Class Current: 600/345
• 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 5/6833 Adhesive patches
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 5/14248 of the skin patch type

Abstract

Disclosed is a skin adherable device for monitoring analytes in interstitial fluid. The device includes an electromagnetic radiation emitting source and a transmitter for transmitting the electromagnetic radiation between the electromagnetic radiation emitting source and the interstitial fluid. The device further includes a detector, operating electronics and a power supply. The device may include a reusable part and a disposable part.

Claims

1-24. -24. (canceled)

25. A device for monitoring one or more body analytes within the body of a patient, the device comprising:

at least one source external to the body for emitting electromagnetic radiation;

at least one detector external to the body for receiving electromagnetic radiation; and

at least one subcutaneously insertable probe having a proximal portion and a distal portion, the proximal portion being positioned external to the body after insertion of the probe, and the distal portion configured for placement within subcutaneous tissue of the patient upon insertion of the probe;

wherein the at least one subcutaneously insertable probe enables;

transmission of electromagnetic radiation in a first direction from the at least one source to the subcutaneous tissue, and

transmission of electromagnetic radiation that interacts with the one or more body analytes in a second direction opposite to the first direction from the subcutaneous tissue to the at least one detector.

26. The device as in claim 25, further comprising a processor configured for determining the one or more body analytes concentrations levels based on a signal generated by the detector.

27. The device as in claim 25, further comprising an optical element for enabling the transmission of electromagnetic radiation, the optical element selected from a group consisting of:

windows, mirrors, reflectors, lenses optical fibers, optical bundles, and combinations thereof.

28. The device as in claim 27, wherein the optical element is a part of the at least one subcutaneously insertable probe.

29. The device as in claim 25, wherein the at least one subcutaneously insertable probe includes at least one opening for electromagnetic radiation transmission between the at least one subcutaneously insertable probe and the subcutaneous tissue.

30. The device as in claim 25, wherein the at least one subcutaneously insertable probe comprises fluorescent molecules.

31. The device as in claim 25, wherein the at least one subcutaneously insertable probe comprises a permeable or semi-permeable membrane enabling diffusion of the one or more body analytes into the at least one subcutaneously insertable probe from the subcutaneous tissue.

32. The device as in claim 25, further comprising a second subcutaneously insertable probe.

33. The device as in claim 32, wherein the second subcutaneously insertable probe comprises a reflector rod.

34. The device as in claim 25, wherein the at least one subcutaneously insertable probe comprises a first probe and a second probe, and wherein:

the first probe includes at least one source fiber for transmitting the electromagnetic radiation in the first direction; and

the second probe includes at least one detector fiber for transmitting the electromagnetic radiation in the second direction.

35. The device as in claim 25, wherein the at least one subcutaneously insertable probe includes a plurality of optical fibers of varying lengths.

36. The device as in claim 25, wherein the at least one subcutaneously insertable probe includes at least one bent optical fiber.

37. The device as in claim 25 further comprising:

a reusable part including the at least one source and the at least one detector; and

a disposable part being in mechanical contact with the proximal portion of the at least one subcutaneously insertable probe, wherein upon connection of the reusable part and disposable part, optical communication is established therebetween.

38. The device as in claim 37, wherein optical communication is established via at least one optical element selected from a group consisting of:

windows, mirrors, reflectors, lenses optical fibers and optical bundles.

39. The device as in claim 25, further comprising a cradle, wherein the cradle includes:

an adhesive layer for adhering the cradle to the skin of the patient;

an opening providing a passageway for the at least one subcutaneously insertable probe; and

one or more connectors for connecting at least one of the device and the at least one subcutaneously insertable probe to the cradle.

40. The device as in claim 25, further comprising a remote control unit for providing programming, data acquisition and displaying of information associated with the programming and/or operation of the device.

41. The device as in claim 25, further comprising a display and/or at least one operating switch.

42. The device as in claim 25, wherein the at least one detector employs at least one of:

optical detection, electrochemical detection, acoustic detection, and any combination thereof.

43. The device as in claims 25, further comprising at least one housing having a pump for delivering a therapeutic fluid to the body of the patient.

44. The device as in claims 43, wherein the therapeutic fluid is delivered to the body of the patient via the at least one subcutaneously insertable probe.

45. The device as in claim 43, wherein the at least one subcutaneously insertable probe comprises a first probe and a second probe, and wherein the first probe enables electromagnetic radiation transmission and the second probe enables delivery of therapeutic fluid.

46. The device as in claims 43, wherein the pump delivers the therapeutic fluid in response to a detected concentration level of the one or more body analytes.

47. A method for monitoring one or more body analytes concentration levels, the method comprising:

providing at least one source for emitting electromagnetic radiation, at least one detector for detecting electromagnetic radiation, and at least one subcutaneously insertable probe having a proximal portion and a distal portion, wherein the at least one source, the at least one detector, and the proximal portion of the probe being external to the body, and the distal portion being configured for placement within subcutaneous tissue of a patient;

emitting electromagnetic radiation from the at least one source, via the at least one subcutaneously insertable probe, into the subcutaneous tissue;

collecting the electromagnetic radiation that interacts with the one or more body analytes;

transmitting the collected electromagnetic radiation, via the at least one subcutaneously insertable probe to the at least one detector; and

determining a concentration level of the one or more body analytes based on the collected electromagnetic radiation.

48. The method as in claim 47, wherein the monitoring of the one or more body analytes is accomplished using at least one of the following optical detection methods:

visible, near infrared (NIR) reflectance, mid-infrared (MIR), infrared (IR), spectroscopy, light scattering, Raman scattering, fluoroscopy, polarimetry, photoacoustic spectroscopy, and combinations thereof.

49. The method as in claim 47, wherein determining the concentration level of the one or more body analytes is based on at least one of:

optical detection, electrochemical detection, acoustic detection, and any combinations thereof.

50. The method as in claim 47, further comprising delivering a therapeutic fluid to the body of the patient based on the determined concentration level of the one or more body analytes.

51. The method as in claim 47, wherein the monitoring of the one or more body analytes is continuous.

52. The method as in claim 47, wherein determining the concentration level of the one or more body analytes comprises spectral analysis of the collected electromagnetic radiation.