Hypodermic optical monitoring of bodily analyte

• US 8,615,281 B2
• Filed: 11/20/2008
• Issued: 12/24/2013
• Est. Priority Date: 11/21/2007
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Gescheit, Iddo M., Gescheit, Illai, Kaidar, Ruthy
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan
• Application Number:
  US12/744,260
• Publication Number:
  US 20100249558A1
• Time in Patent Office: 1,860 Days
• Field of Search: 600/310, 600/316, 600/322, 600/323, 600/326, 600/327, 600/329, 600/332, 600/338, 600/339, 600/340, 600/341, 600/342, 600/344, 600/473, 600/476
• US Class Current: 600/342
• 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. A device for monitoring one or more body analytes within the body of a patient, the device comprising:

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

at least one detector configured to be positioned external to the body for receiving electromagnetic radiation;

a plurality of subcutaneously insertable probes comprising a first probe and a second probe, each having a proximal portion configured to be positioned external to the body after insertion of the probe, and a distal portion configured for placement within a subcutaneous tissue of the patient upon insertion of the probe;

wherein the first probe is configured to;

transmit electromagnetic radiation from the at least one source to the subcutaneous tissue and toward the second probe to enable the electromagnetic radiation to interact with the one or more analytes being monitored, and

transmit the electromagnetic radiation that has interacted with the one or more body analytes from the subcutaneous tissue to the at least one detector.

2. The device as in claim 1, further comprising a processor configured for determining the one or more body analytes concentrations levels based on a signal generated by the detector.

3. The device as in claim 1, 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.

4. The device as in claim 3, wherein the optical element is a part of the first subcutaneously insertable probe.

5. The device as in claim 1, wherein the first probe includes at least one lateral electromagnetic radiation opening for electromagnetic radiation transmission between the at least one subcutaneously insertable probe and the subcutaneous tissue.

6. The device as in claim 1, wherein the second subcutaneously insertable probe comprises a reflector rod.

7. The device as in claim 1, wherein the at least one of the subcutaneously insertable probes includes a plurality of optical fibers of varying lengths.

8. The device as in claim 1, wherein the at least one of the subcutaneously insertable probes includes at least one bent optical fiber.

9. The device as in claim 1 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 subcutaneously insertable probes, wherein upon connection of the reusable part and disposable part, optical communication is established therebetween.

10. The device as in claim 9, 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.

11. The device as in claim 1, further comprising a cradle, wherein the cradle includes:

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

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

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

12. The device as in claim 1, 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.

13. The device as in claim 1, further comprising a display and/or at least one operating switch.

14. The device as in claim 1, further comprising at least one housing having a pump for delivering a therapeutic fluid to the body of the patient.

15. The device as in claim 14, wherein the therapeutic fluid is delivered to the body of the patient via at least one of the subcutaneously insertable probes.

16. The device as in claim 14, wherein the second probe is configured to deliver the therapeutic fluid.

17. The device as in claim 14, wherein the pump delivers the therapeutic fluid in response to a detected concentration level of the one or more body analytes.

18. The device as in claim 1, wherein the first probe comprises at least one optical fiber having an outer layer, the outer layer of the optical fiber defining one or more openings along a longitudinal length of the fiber to allow the electromagnetic radiation to be transmitted therethrough.

19. 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 a plurality of subcutaneously insertable probes comprising a first probe and a second probe, each having a proximal portion and a distal portion, wherein the at least one source, the at least one detector, and the proximal portions of the probes are configured to be positioned external to the body, and the distal portions are configured for placement within subcutaneous tissue of a patient;

emitting electromagnetic radiation from the at least one source, via the first probe, into the subcutaneous tissue and toward the second probe to allow the electromagnetic radiation to interact with the one or more body analytes being monitored;

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

transmitting the collected electromagnetic radiation, via the first 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.

20. The method as in claim 19, 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.

21. The method as in claim 19, 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.

22. The method as in claim 19, wherein the monitoring of the one or more body analytes is continuous.

23. The method as in claim 19, wherein determining the concentration level of the one or more body analytes comprises spectral analysis of the collected electromagnetic radiation.