Device for isolating regions of living tissue

• US 6,631,282 B2
• Filed: 10/02/2001
• Issued: 10/07/2003
• Est. Priority Date: 08/09/2001
• Status: Expired due to Fees

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Agostino, Mark D., Cortella, Julian, Braig, James R., Rule, Peter, Goldberger, Daniel S.
• Primary Examiner(s): Winakur, Eric F.
• Application Number:
  US09/970,021
• Publication Number:
  US 20030032872A1
• Time in Patent Office: 735 Days
• Field of Search: 600/310, 600/322, 600/323, 600/340, 600/344
• US Class Current: 600/344
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• 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 5/6841 by using templates

Abstract

A device and method are provided for use with a non-invasive optical measurement system, such as a thermal gradient spectrometer for improved determination of analyte concentrations within living tissue. In a preferred embodiment, a site selector is secured to a patient'"'"'s forearm thereby isolating a measurement site on the patient'"'"'s skin for determination of blood glucose levels. The site selector attaches to a thermal mass window of the spectrometer and thus forms an interface between the patient'"'"'s skin and the thermal mass window. When the spectrometer must be temporarily removed from the patient'"'"'s skin, such as to allow the patient mobility, the site selector is left secured to the forearm so as to maintain a consistent measurement site on the skin. When the spectrometer is later reattached to the patient, the site selector will again form an interface between the gradient spectrometer and the same location of skin as before.

Claims

1. A device for maintaining a predetermined location and orientation on the skin of a patient to facilitate use of a noninvasive optical measurement system having an analysis window for collecting infrared emissions from the patient, the device comprising:

a generally flat rigid member adapted to be coupled to said predetermined location on the under portion of the forearm of the patient, the rigid member having a first generally flat surface for engagement with the optical measurement system and a second generally arcuate surface adapted to conform generally to and engage with the forearm of the patient;

a perimeter portion of said rigid member defining an aperture for receiving the analysis window of the optical measurement system;

at least one protrusion extending from said perimeter into the aperture and adapted to cooperate with the optical measurement system to locate and align the measurement system;

slots formed in the perimeter portion of the rigid member; and

a strap extending through the slots and coupled to the rigid member, the strap having at least one adjustable end and having an adjustable length for causing the perimeter portion of the rigid member to press against the skin of the patient;

wherein the strap and the rigid member cooperate to put pressure on the perimeter portion of the rigid member whereby the perimeter portion grips the skin to ensure thermal contact between the skin and the analysis window through the aperture.

2. The device of claim 1, wherein said aperture is substantially circular and said at least one protrusion comprises a first protrusion and a second protrusion spaced about 180 degrees from said first protrusion.

3. The device of claim 1, wherein said at least one protrusion forms a substantially flat surface that faces toward an inner portion of said aperture.

4. The device of claim 1, further comprising at least one raised section formed on the first surface and configured to align the optical measurement system to the rigid member.

5. The device of claim 4, wherein said at least one raised section comprises a first raised section and a second raised section located on opposite sides of said aperture.

6. The device of claim 1, wherein said rigid member is formed from a material which minimizes formation of condensation on said rigid member.

7. The device of claim 1, wherein said aperture is substantially circular and has a diameter of about 2.0 inches.

8. A device for maintaining a predetermined location and orientation on the skin of a patient to facilitate use of a noninvasive optical measurement system having an analysis window for collecting infrared emissions from the patient, the device comprising:

a generally flat rigid member adapted to be coupled to said predetermined location on the under portion of the forearm of the patient, the rigid member having a first surface configured for engagement with the optical measurement system and a second generally arcuate surface adapted to conform generally to and engage with the forearm of the patient;

an aperture formed in said rigid member for receiving the analysis window of the optical measurement system;

at least one protrusion formed on said rigid member and extending into the aperture and adapted to cooperate with the optical measurement system to locate and align the measurement system; and

a strap coupled to the rigid member, the strap being configured to compress the rigid member against the predetermined location causing the edges of the aperture to press against the skin of the patient, whereby the rigid member grips the skin to ensure thermal contact between the skin and the analysis window through the aperture.

9. The device of claim 8, wherein said aperture is substantially circular and said at least one protrusion comprises a first protrusion and a second protrusion spaced about 180 degrees from said first protrusion.

10. The device of claim 8, wherein said at least one protrusion forms a substantially flat surface that faces toward an inner portion of said aperture.

11. The device of claim 8, further comprising at least one raised section formed on the first surface and configured to align the optical measurement system to the rigid member.

12. The device of claim 11, wherein said at least one raised section comprises a first raised section and a second raised section located on opposite sides of said aperture.

13. The device of claim 8, wherein said rigid member is formed from a material which minimizes formation of condensation on said rigid member.

14. The device of claim 8, wherein said aperture is substantially circular and has a diameter of about 2.0 inches.

15. A method of maintaining a predetermined location on the skin at the under portion of the forearm of a patient to facilitate use of a noninvasive optical measurement system having an analysis window for collecting infrared emissions from the patient, the method comprising:

compressing against the predetermined location a generally flat rigid member having a first generally flat surface configured for engagement with the optical measurement system and a second generally arcuate surface adapted to conform generally to the predetermined location;

causing edges of an aperture formed in the rigid member to press against the skin of the patient; and

while the rigid member is compressed against the predetermined location, placing the noninvasive optical measurement system against the first surface of the rigid member and aligning the measurement system by employing a protrusion that is formed on the rigid member and extends into the aperture.

16. The method of claim 15, wherein compressing comprises adjusting the length of a strap coupled to said rigid member.

17. The method of claim 15, wherein aligning comprises employing first and second protrusions located on opposite sides of said aperture.

18. The method of claim 15, wherein aligning further comprises employing a raised portion located on said first surface.

19. The method of claim 15, wherein aligning further comprises employing a first and second raised portion located on said first surface, on opposite sides of said aperture.

20. The method of claim 15, further comprising applying at least one alignment mark to said predetermined location.

21. The method of claim 20, further comprising aligning said rigid member with said at least one alignment mark.

22. The method of claim 20, wherein said alignment mark comprises a first alignment mark and a second alignment mark, the first alignment mark corresponding with a first side of the aperture and the second alignment mark corresponding with a second side of the aperture.