Non-invasive near-infrared quantitative measurement instrument

• US 5,237,178 A
• Filed: 12/30/1991
• Issued: 08/17/1993
• Est. Priority Date: 06/27/1990
• Status: Expired due to Term

• Current Assignee: John J. Mastrototaro, Joseph K. Frischmann, Robert D. Rosenthal
• Original Assignee: John J. Mastrototaro, Joseph K. Frischmann, Robert D. Rosenthal
• Inventors: Mastrototaro, John J., Frischmann, Joseph K., Rosenthal, Robert D.
• Primary Examiner(s): Dzierzynski, Paul M.
• Assistant Examiner(s): HANIG, RICHARD E
• Application Number:
  US07/813,739
• Time in Patent Office: 596 Days
• Field of Search: 250/341, 250/339, 250/343, 250/346, 356/39, 128/633
• US Class Current: 250/341.7
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 5/02422 within occluders
• CPC Class Codes: A61B 5/02433 for infrared radiation
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

An improved near-infrared quantitative analysis instrument is disclosed comprising a removable finger insert which facilitates properly aligning and fitting and individual user'"'"'s finger into the optical system of the analysis instrument. The finger insert according to the present invention also prevents the analysis instrument'"'"'s optical system from being damaged by foreign matter typically introduced by a user'"'"'s finger. The finger insert can also be provided with filters which will enable the insert to be used to as an optical standard for the analysis instrument.

Claims

1. A near-infrared quantitative analysis instrument for non-invasive measurement of a blood analyte present in a body part of a subject, said analysis instrument comprising:

(a) introducing means including a near-infrared energy source for introducing near-infrared energy into blood present in a body part of a subject;

(b) detecting means for detecting near-infrared energy emerging from the body part;

(c) a housing means for housing at least said introducing means and said detecting means, said housing means comprising a chamber means for enabling said body part of said subject to be exposed to said near-infrared energy, said introducing means and said detecting means being positioned about said chamber means such that near-infrared energy emitted by said introducing means is receivable by said detecting means;

(d) an insert means for receiving said body part of said subject and for engaging said chamber means, said insert means comprising window means for permitting said near-infrared energy emitted from said introducing means to pass through said insert means and to be receivable by said detecting means; and

(e) processing means for calculating an electrical signal from said detection means into a signal indicative of the quantity of said blood analyte present in the blood of the subject.

2. The near-infrared analysis instrument as set forth in claim 1, wherein said insert means removably engages said chamber means.

3. The near-infrared analysis instrument as set forth in claim 2, wherein said insert means is disposable.

4. The near-infrared analysis instrument as set forth in claim 1, wherein said window means comprises at least one optical opening which is transparent to near-infrared energy.

5. The near-infrared analysis instrument as set forth in claim 4, wherein said window means comprises two optical openings which are transparent to near-infrared energy.

6. The near-infrared analysis instrument as set forth in claim 1, wherein said housing means comprises a temperature sensing means for sensing the temperature of the subject'"'"'s body part.

7. The near-infrared analysis instrument as set forth in claim 6, wherein said insert means comprises a conduction means for transferring energy representative of the subject'"'"'s body part temperature to said temperature sensing means.

8. The near-infrared analysis instrument as set forth in claim 1, wherein said insert means has a constant outside diameter and an inner diameter selected to securely engage the subject'"'"'s body part.

9. The near-infrared analysis instrument as set forth in claim 1, wherein said analysis instrument further comprises a light protection means for shielding stray light from interfering with blood analyte calculations.

10. The near-infrared analysis instrument as set forth in claim 9, wherein said light protection means comprises a light opaque bellows which covers a portion of the subject'"'"'s body part which extends outside the analysis instrument.

11. The near-infrared analysis instrument as set forth in claim 10, wherein said bellows is mounted on said housing means.

12. The near-infrared analysis instrument as set forth in claim 10, wherein said bellows is mounted on said insert means.

13. The near-infrared analysis instrument as set forth in claim 1, wherein said insert means comprises an alignment means for guiding the insert means into said chamber means.

14. The near-infrared analysis instrument as set forth in claim 13, wherein said alignment means comprises alignment rails positioned on said insert means.

15. The near-infrared analysis instrument as set forth in claim 1, wherein said analysis instrument further comprises a safety means for inactivating the analysis instrument after said insert means has been operated for a predetermined period of use.

16. The near-infrared analysis instrument as set forth in claim 15, wherein said safety means comprises an electrical circuit connecting at least a useful life regulation means inside said insert means with a means for controlling operation of the instrument.

17. The near-infrared analysis instrument as set forth in claim 16, wherein said useful life regulation means comprises a filament which expends after a predetermined period of use.

18. The near-infrared analysis instrument as set forth in claim 5, wherein said inset means is substantially opaque to light except through said window means.

19. The near-infrared analysis instrument as set forth in claim 1, wherein said inset means further includes a holding means for properly positioning an individual'"'"'s body part in said insert means.

20. The near-infrared analysis instrument as set forth in claim 19, wherein said holding means comprises a lining which engages said body part.

21. The near-infrared analysis instrument as set forth in claim 19, wherein said holding means further includes a abutment means for preventing further insertion of said body part into said insert means.

22. The near-infrared analysis instrument as set forth in claim 15, wherein said safety means comprises means for storing a first empty chamber measurement and comparing said first empty chamber measurement with a subsequent empty chamber measurement and means inactivating said analysis instrument if a value of said first empty chamber measurement is different from a value of said subsequent empty chamber measurement by a predetermined amount.

23. The near-infrared analysis instrument as set forth in claim 1, further comprising means for providing an optical standard for said analysis instrument, said means for providing an optical standard comprising said insert means having an optical filter means for passing near-infrared energy from said source to said detection means.

24. The near-infrared analysis instrument as set forth in claim 23, wherein said optical filter means comprises a first optical filter and a second optical wherein said first and second optical filter are positioned 180 degrees from one another.