Sample adapter

• US 20030060694A1
• Filed: 08/15/2002
• Published: 03/27/2003
• Est. Priority Date: 08/16/2001
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Gable, Jennifer H., Braig, James R., Hartstein, Philip C., Rule, Peter
• Granted Patent: US 6,771,993 B2
• Time in Patent Office: Days
• US Class Current: 600/322
• 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 5/1491 Heated applicators
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

Abstract

An adapter presents a sample of bodily fluid, such as whole blood, including an analyte to an analyzer window of a non-invasive monitor. The adapter comprises a base material that comprises a first side and a second side. The adapter also comprises a sample accommodating volume extending between an opening in the second side of the base material and an opening in the first side of the base material.

Claims

1. An adapter for presenting a sample of body fluid including an analyte to a window of a noninvasive analyte detection system, the adapter comprising:

a base material comprising a first side and a second side; and

a sample accommodating volume extending between an opening in the second side of the base material and an opening in the first side of the base material.

2. The adapter of claim 1, further comprising an adhesive layer comprising a first side and a second side, the second side of the adhesive layer positioned proximate the first side of the base material, the adhesive layer configured to releasably adhere the adapter to the window.

3. The adapter of claim 1, wherein the first side of the base material has a length that is no greater than the length of the window, and a width that is no greater than the width of the window.

4. The adapter of claim 2, wherein the adhesive layer is formed of a material that emits infrared radiation in different wavelengths than the analyte.

5. The adapter of claim 2, wherein the adhesive layer is configured to passivate the window in contact with the adhesive.

6. The adapter of claim 1, further comprising a wicking medium positioned in the sample accommodating volume, the wicking medium configured to retain the sample within the sample accommodating volume.

7. The adapter of claim 6, wherein the wicking medium is made of a material capable of exerting capillary forces on a volume of the sample.

8. An adapter for presenting a sample of whole blood including an analyte to a window of a noninvasive analyte detection system, the adapter comprising:

a base material comprising a first side and a second side;

an optically transparent layer comprising a first side and a second side, the second side of the optically transparent layer positioned proximate the first side of the base material; and

a sample accommodating volume extending between the second side of the optically transparent layer and an opening in the second side of the base material.

9. The adapter of claim 8, further comprising an adhesive layer comprising a first side and a second side, the first side of the adhesive layer configured to releasably adhere to the window, the second side of the adhesive layer positioned proximate the first side of the optically transparent layer.

10. The adapter of claim 8, wherein the optically transparent layer is less than one-half the thickness of the base material.

11. An adapter for presenting a sample of whole blood including an analyte to a window of a noninvasive analyte detection system, the adapter comprising:

a base material comprising a first side having a first opening and a second side having a second opening; and

a sample accommodating volume formed in the base material and extending between the first opening and the second opening.

12. The adapter of claim 11, further comprising an adhesive layer comprising a first side and a second side, the first side of the adhesive layer configured to releasably adhere to the window, the second side of the adhesive layer proximate the first side of the base material.

13. The adapter of claim 11, further comprising a neutral absorption material positioned in the sample accommodating volume.

14. A method for calibrating a noninvasive detection unit including a window, the method comprising:

withdrawing a sample of bodily fluid from a patient;

positioning the sample over the window;

analyzing the sample with the noninvasive detection unit and generating an invasive-measurement output representing the concentration of an analyte;

placing the window in contact with the skin of the patient;

analyzing the patient'"'"'s tissue with the noninvasive detection unit and generating a noninvasive-measurement output representing the concentration of the analyte;

comparing the invasive-measurement output and the noninvasive-measurement output to estimate an error; and

correcting the noninvasive-measurement output based on said error.

15. The method of claim 14, wherein positioning the sample over the window comprises positioning the sample in a sample adapter, and placing the sample adapter on the window.

16. The method of claim 14, wherein placing the window in contact with the skin of the patient further comprises placing a thermal gradient inducing means in contact with the skin of the patient.

17. The method of claim 14, further comprising correcting subsequent noninvasive-measurement outputs based on said error.

18. A method for calibrating a noninvasive detection unit including a window, the method comprising:

determining whether there is a restricted period in effect;

selecting an on-site or an alternative site measurement location based on whether a restricted period is in effect;

withdrawing an sample of bodily fluid from a patient at the selected measurement location, the sample comprising at least one analyte;

positioning the sample over the window;

analyzing the analyte in the sample using the noninvasive detection unit and generating an invasive-measurement output representing a characteristic of the analyte;

placing the window of the noninvasive detection unit in contact with the skin of the patient;

analyzing the analyte in the tissue of the patient with the noninvasive detection unit;

generating a noninvasive-measurement output representing the characteristic of the analyte;

comparing the invasive-measurement output and the noninvasive-measurement output to estimate an error; and

correcting the noninvasive-measurement output based on said error.

19. The method of claim 18, wherein placing the window of the noninvasive detection unit in contact with the skin of the patient comprises placing the window in contact with the skin of the patient at the on-site measurement location or at the alternative site measurement location based on whether a restricted period is in effect.

20. The method of claim 18, wherein placing the window of the noninvasive detection unit in contact with the skin of the patient further comprises placing a thermal gradient inducing element of said noninvasive detection unit in contact with the skin of the patient.

21. The method of claim 18, further comprising correcting subsequent noninvasive outputs based on said error.

22. The method of claim 18, wherein generating an invasive-measurement output representing a characteristic of the analyte comprises generating an invasive-measurement output representing the concentration of glucose in blood.

23. The method of claim 18, wherein determining whether there is a restricted period in effect comprises measuring an amount of time since a subject has eaten.

24. The method of claim 23, wherein the amount of time measured is from about 0.5 hour to about 3 hours.

25. The method of claim 23, wherein the amount of time measured is from about 1 hours to about 2 hours.

26. The method of claim 23, wherein the amount of time measured is from about 1.5 hours to about 2 hours.

27. The method of claim 23, wherein the amount of time measured is about 2 hours.