Device for enhancement and quality improvement of blood-related signals for use in a system for non-invasive measurements of blood-related signals

• US 6,731,963 B2
• Filed: 09/07/2001
• Issued: 05/04/2004
• Est. Priority Date: 03/09/1999
• Status: Active Grant

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: Fine, Ilya, Finarov, Alexander
• Primary Examiner(s): Hindenbrug, Mak F.
• Assistant Examiner(s): Kremer, Matthew
• Application Number:
  US09/948,900
• Publication Number:
  US 20020077535A1
• Time in Patent Office: 970 Days
• Field of Search: 600/322-323, 600/335, 600/334, 600/344
• US Class Current: 600/335
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips

Abstract

A disposable device is presented aimed at enhancing blood-related signals and improving their quality during non-invasive measurements of blood parameters. The device is applicable to a patient'"'"'s finger or toe, and comprises a cover for wrapping at least a part of the finger or toe including a tip portion thereof in a manner to provide even pressurization of tissue within the wrapped portion with a pressure less than a systolic pressure. This results in enhancement and quality improvement of the measured blood-related signal. The cover is elastic and is shiftable along a longitudinal axis of the finger or toe between an inoperative folded position of the cover and an operative extracted position of the cover, in which it wraps the finger or toe portion including the tip portion and provides said even pressurization of the entire wrapped tissue. At least a portion of the cover is made of a material enabling the non-invasive measurements of the blood-related signal therethrough.

Claims

1. A disposable device for use in a method of non-invasive measurements of blood-related signals from a portion of a patient'"'"'s finger or toe, wherein the method includes application of pressure, substantially less than a systolic pressure, to the portion of the patient'"'"'s finger or toe in a manner provide even pressurization of said portion, application of an external field to a measurement location within the pressed portion, detection of a response of the measurement location to said external field, and generation of data indicative of blood-related signals, the device comprising:

a cover for wrapping at least a portion of the finger or toe, to thereby provide the even pressurization of the entire wrapped portion;

said cover being elastic, having a substantially circular cross-section, and being shiftable along a longitudinal axis of the finger or toe between an inoperative folded position of the cover and an operative extracted position of the cover, in which the cover wraps the finger or toe portion including tip portion and provides said even pressurization of the entire wrapped tissue with the pressure less than the systolic pressure;

at least a portion of the cover being made of a material enabling the non-invasive measurements of the blood-related signal through said at least portion of the cover, said even pressurization of the body portion under measurement provided by the device resulting in that said response is at least two times higher than that obtained with no such even pressurization.

2. The device according to claim 1, wherein said cover in its folded inoperative position presents a rolled spherically-shaped segment, and is unrollable into the operative extracted position thereof to wrap the finger or toe portion including the tip portion.

3. The device according to claim 1, wherein said cover has a flat circular geometry when in the inoperative position thereof, and is stretchable into the operative extracted position thereof to wrap the finger or toe portion including the tip portion.

4. The device according to claim 2, wherein said cover is formed with a locking assembly, which, when in the inoperative position of the cover, extends along at least a part of a circumferential periphery region of the cover.

5. The device according to claim 3, wherein said cover is formed with a locking assembly, which, when in the inoperative position of the cover, extends along at least a part of a circumferential periphery region of the cover.

6. The device according to claim 4, wherein said locking assembly, when in the inoperative position of the cover, is in the form of a strap, which forms a ring when in the operative position of the cover, said strap being flexible to enable twisting of its ends, thereby enabling adjustment of the ring diameter to apply a desired pressure.

7. The device according to claim 5, wherein said locking assembly, when in the inoperative position of the cover, is in the form of a strap, which forms a ring when in the operative position of the cover, said strap being flexible to enable twisting of its ends, thereby enabling adjustment of the ring diameter to apply a desired pressure.

8. The device according to claim 4, wherein said locking assembly is a ring having a preset stretching force and extending along the entire circumferential periphery region of the cover when in the inoperative position thereof, shifting the cover into the operative position thereof resulting in that a force applied to the ring exceeds said preset stretching force, thereby causing tearing off of the ring.

9. The device according to claim 5, wherein said locking assembly is a ring having a preset stretching force and extending along the entire circumferential periphery region of the cover when in the inoperative position thereof, shifting the cover into the operative position thereof resulting in that a force applied to the ring exceeds said preset stretching force, thereby causing tearing off of the ring.

10. The device according to claim 4, wherein said locking assembly comprises first and second rings extending along two successive circumferential regions at the periphery of the cover, the first ring being twistable to stretch the cover, when in the operative position thereof, and the second ring serving as a locking mechanism, preventing movement of said first ring being twisted along the finger or toe.

11. The device according to claim 5, wherein said locking assembly comprises first and second rings extending along two successive circumferential regions at the periphery of the cover, the first ring being twistable to stretch the cover, when in the operative position thereof, and the second ring serving as a locking mechanism, preventing movement of said first ring being twisted along the finger or toe.

12. The device according to claim 1, and also comprising a heating assembly for heating said tissue through said cover.

13. The device according to claim 12, wherein said heating assembly comprises a heating element formed by a conductive material associated with a voltage supply source.

14. The device according to claim 13, wherein

said cover in its folded inoperative position presents a rolled spherically-shaped segment, and is unrollable into its operative extracted position to wrap the finger or toe portion including the tip portion;

said heating element is made of flexible material to be shiftable together with the cover between an inoperative rolled position of the heating element and an operative unrolled position of the heating element, in which the heating element is located above the unrolled cover.

15. The device according to claim 1, wherein the entire cover is transparent to predetermined incident radiation used in the non-invasive measurements, the cover being sufficiently thin to prevent the detection of radiation rounding the wrapped portion.

16. The device according to claim 15, wherein said predetermined radiation is sound.

17. The device according to claim 15, wherein said cover is made of a material enabling electrical current to be induced in the wrapped tissue.

18. The device according to claim 15, wherein the cover has a thickness of about 0.1-0.2 mm.

19. The device according to claim 1, wherein said cover is made of at least one material selected from the group including:

rubber, silicone, latex, PVC, nylon, paraffin, polyethylene.

20. The device according to claim 1, wherein the cover has two portions thereof made of a material substantially transparent with respect to predetermined radiation, said two portions being surrounded by a material of the cover substantially non-transparent with respect to said predetermined radiation.

21. The device according to claim 20, wherein said two portions are located diametrically opposite to each other.

22. The device according to claim 20, wherein the surrounding material is composed of said material substantially transparent for the predetermined radiation waves and is composed of predetermined pigments providing the non-transparency of the surrounding material.

23. The device according to claim 22, wherein said predetermined pigments include at least one from the following list:

carbon, titanium oxide, BaS and BaSO₄.

24. The device according to claim 1, for use measuring the optical response of the measurement location to predetermined incident radiation.

25. The device according to claim 24, for use in occlusion-based non-invasive optical measurements, wherein over-systolic pressure is additionally applied to the patient'"'"'s blood-perfused medium.

26. The device according to claim 1, for use in measuring the response in the form of an impedance resulting from an application of the external electrical field.