Conformal pulse oximetry sensor and monitor

• US 5,817,008 A
• Filed: 10/31/1996
• Issued: 10/06/1998
• Est. Priority Date: 10/31/1996
• Status: Expired due to Term

• Current Assignee: Spacelabs Healthcare LLC (OSI Systems Incorporated)
• Original Assignee: Spacelabs Medical Incorporated (OSI Systems Incorporated)
• Inventors: Kahn, Alan, Marble, David R., Pelikan, Glenn W., Rafert, Stephen C.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/741,735
• Time in Patent Office: 705 Days
• Field of Search: 128/633, 128/664, 128/665, 128/666, 356/41, 600/310, 600/322, 600/323, 600/340, 600/344, 600/473, 600/476
• US Class Current: 600/323
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor

Abstract

An optoelectronic pulse oximetry sensor is described which physically conforms to a body portion of a patient, such as a finger, and provides a firm pressing engagement between the sensor and the patient'"'"'s body portion. The sensor includes a flexible substrate, such as an elastic bandage-type material, which is physically conformable and attachable/adherable to the patient'"'"'s body portion. The sensor also includes a light source assembly for transilluminating the patient'"'"'s body portion, and a light detector assembly for measuring transmitted light. The dimensions of the light source and light detector assemblies are constructed to provide a high aspect ratio relative to the flexible substrate. When the sensor is conformably applied to the patient'"'"'s body portion, localized pressure is exerted on the body portion at the points of contact with the light source and light detector assemblies, thereby stressing the skin and the underlying blood-perfused tissue. The stress imparted to the skin and underlying tissues affects the distributions of blood in the tissues and provides improved accuracy and sensitivity in arterial oxygen saturation measurement, especially in circumstances of low perfusion.

Claims

1. An optoelectronic sensor removably securable to a body portion of a patient, comprising:

an elastic substrate having an inner surface for disposition towards the body portion and an outer surface for disposition away from the body portion;

a light source assembly mounted on the elastic substrate; and

a light detector assembly mounted on the elastic substrate;

wherein at least one of the light source and light detector assemblies projects away from the inner surface of the elastic substrate, and wherein the elastic substrate is adapted to press the one of the light source and light detector assemblies into firm pressing engagement with the body portion to exert a localized pressure thereon.

2. The sensor of claim 1 wherein the light source assembly comprises a light source and a substantially rigid transparent housing enclosing the light source.

3. The sensor of claim 2 wherein the substrate comprises inner and outer substrate layers, and wherein the transparent housing comprises a hollow body portion having a transparent cover portion at one end and a flange at the other end, the flange being positioned between the inner and outer substrate layers with the cover portion projecting through a hole in the inner substrate layer.

4. The sensor of claim 1 wherein the light detector assembly comprises a light detector and a substantially rigid transparent housing enclosing the light detector.

5. The sensor of claim 4 wherein the substrate comprises inner and outer substrate layers, and wherein the transparent housing comprises a hollow body portion having a transparent cover portion at one end and a flange at the other end, the flange being positioned between the inner and outer substrate layers with the cover portion projecting through a hole in the inner substrate layer.

6. The sensor of claim 1 wherein the light source assembly comprises:

a light source;

a substantially rigid circuit board for holding the light source and providing electrical connections thereto; and

a substantially elastomeric transparent cover connected to the circuit board and covering the light source.

7. The sensor of claim 6 wherein the light source assembly further includes an elastomeric layer attached to the flexible substrate on a first side and attached to the circuit board on a second side.

8. The sensor of claim 1 wherein the light detector assembly comprises:

a light detector;

a substantially rigid circuit board for holding the light detector and providing electrical connections thereto; and

a substantially elastomeric transparent cover connected to the circuit board and covering the light detector.

9. The sensor of claim 8 wherein the light detector assembly further includes an elastomeric layer attached to the elastic substrate on a first side and attached to the circuit board on a second side.

10. The sensor of claim 1 wherein the elastic substrate includes:

an outer layer providing the outer surface;

an inner layer attached to the outer layer and providing the inner surface, the inner layer having an opening; and

wherein the light source assembly is attached to the elastic substrate at a location between the inner and outer layers and extends through the opening in the inner layer.

11. The sensor of claim 10 wherein the light source assembly includes a substantially rigid transparent housing enclosing the light source and having a flange portion and a cover portion, the flange portion being held between the outer and inner layers to attach the light source assembly to the elastic substrate, and the cover portion projecting through the opening in the inner layer.

12. The sensor of claim 10 wherein a plurality of electric wires carrying electric signals to and from the light source and light detector assemblies are partly held between the outer and inner layers.

13. An optoelectronic sensor removably securable to a body portion of a patient and having a light source for transilluminating the body portion and a light detector for measuring transmitted light, the sensor comprising:

a flexible substrate having an inner surface for disposition towards the body portion and an outer surface for disposition away from the body portion, the flexible substrate providing a substantially uniform pressure on the body portion;

a light source assembly connected to the flexible substrate and projecting from the inner surface a distance that is not less than approximately a distance that the light source assembly extends along the inner surface, the light source assembly thereby adapted to exert a first localized pressure against the body portion beneath the light source assembly to stress skin beneath the light source assembly; and

a light detector assembly connected to the flexible substrate and projecting from the inner surface a distance that is not less than approximately a distance that the light detector assembly extends along the inner surface, the light detector assembly thereby adapted to exert a second localized pressure against the body portion beneath the light detector assembly to stress skin beneath the light detector assembly.

14. The sensor of claim 13 wherein the flexible substrate includes a plurality of layers.

15. The sensor of claim 13 wherein the first and second localized pressures are approximately equal.

16. An optoelectronic sensor removably securable to a body portion of a patient and having a light source for transilluminating the body portion and a light detector for measuring transmitted light, the sensor comprising:

a flexible substrate physically conformable to the body portion and including an outer layer and an inner layer, the inner layer attached to the outer layer and having a first opening and a second opening;

a light source assembly including a first substantially rigid transparent housing enclosing the light source and having a first flange portion and a first cover portion, the flange portion being positioned between the outer and inner layers to secure the light source assembly to the flexible substrate, the first cover portion projecting through the first opening in the inner layer and having an aspect ratio relative to the flexible substrate of not less than approximately 1;

1, the light source assembly thereby adapted to exert a localized pressure against the body portion beneath the light source assembly to stress skin beneath the light source assembly; and

a light detector assembly including a second substantially rigid transparent housing enclosing the light detector and having a second flange portion and a second cover portion, the second flange portion being positioned between the outer and inner layers to secure the light detector assembly to the flexible substrate, the second cover portion projecting through the second opening in the inner layer and having an aspect ratio relative to the flexible substrate of not less than approximately 1;

1, the light detector assembly thereby adapted to exert a localized pressure against the body portion beneath the light detector assembly to stress skin beneath the light detector assembly.

17. The sensor of claim 16 wherein the light source assembly includes a plurality of light-emitting diodes.

18. A pulse oximetry monitoring system, comprising:

an optoelectronic sensor removably securable to a body portion of a patient, comprising;

a flexible substrate having an inner surface for disposition towards, the body portion and an outer surface for disposition away from the body portion;

a light source assembly mounted on the flexible substrate, the light source assembly projecting away from the inner surface a distance that is not less than approximately a distance the light source assembly extends along the inner surface, the light source assembly thereby adapted to exert localized pressure on the body portion beneath the light source assembly when the sensor is attached to the body portion; and

a light detector assembly mounted on the flexible substrate, the light detector assembly projecting away from the inner surface a distance that is not less than approximately a distance the light detector assembly extends along the inner surface, the light detector assembly thereby adapted to exert localized pressure on the body portion beneath the light detector assembly when the sensor is attached to the body portion; and

a pulse oximetry monitor electrically coupled to the optoelectronic sensor, the monitor applying a drive signal to the light source assembly, receiving a signal from the light detector assembly, and determining the percentage of oxygen saturation of blood in tissue in the body portion of the patient between the light emitter assembly and the light detector assembly.

19. The pulse oximetry monitoring system of claim 18 wherein the light source assembly comprises a light source and a substantially rigid transparent housing enclosing the light source.

20. The pulse oximetry monitoring system of claim 19 wherein the substrate comprises inner and outer substrate layers, and wherein the transparent housing comprises a hollow body portion having a transparent cover portion at one end and a flange at the other end, the flange being positioned between the inner and outer substrate layers with the cover portion projecting through a hole in the inner substrate layer.

21. The pulse oximetry monitoring system of claim 18 wherein the light detector assembly comprises a light detector and a substantially rigid transparent housing enclosing the light detector.

22. The pulse oximetry monitoring system of claim 21 wherein the substrate comprises inner and outer substrate layers, and wherein the transparent housing comprises a hollow body portion having a transparent cover portion at one end and a flange at the other end, the flange being positioned between the inner and outer substrate layers with the cover portion projecting through a hole in the inner substrate layer.

23. The pulse oximetry monitoring system of claim 18 wherein the light source assembly comprises:

a light source;

a substantially rigid circuit board for holding the light source and providing electrical connections thereto; and

a substantially elastomeric transparent cover connected to the circuit board and covering the light source.

24. The pulse oximetry monitoring system of claim 23 wherein the light source assembly further includes an elastomeric layer attached to the flexible substrate on a first side and attached to the circuit board on a second side.

25. The pulse oximetry monitoring system of claim 18 wherein the light detector assembly comprises:

a light detector;

a substantially rigid circuit board for holding the light detector and providing electrical connections thereto; and

a substantially elastomeric transparent cover connected to the circuit board and covering the light detector.

26. The pulse oximetry monitoring system of claim 25 wherein the light detector assembly further includes an elastomeric layer attached to the flexible substrate on a first side and attached to the circuit board on a second side.

27. The pulse oximetry monitoring system of claim 18 wherein the flexible substrate includes:

an outer layer providing the outer surface;

an inner layer attached to the outer layer and providing the inner surface, the inner layer having an opening; and

wherein the light source assembly is attached to the flexible substrate at a location between the inner and outer layers and extends through the opening in the inner layer.

28. The pulse oximetry monitoring system of claim 24 wherein the light source assembly includes a substantially rigid transparent housing enclosing the light source and having a flange portion and a cover portion, the flange portion being held between the outer and inner layers to attach the light source assembly to the flexible substrate, and the cover portion projecting through the opening in the inner layer.

29. The pulse oximetry monitoring system of claim 27 wherein a plurality of electric wires carrying electric signals to and from the light source and light detector assemblies are partly held between the outer and inner layers.

30. A method of measuring the arterial oxygen saturation level in a patient, comprising the steps of:

physically conforming an arterial oxygen saturation level sensor to a body portion of the patient;

directing light into the body portion at a light source region of the body portion;

detecting light transmitted through the body portion at a light detection region of the body portion; and

exerting a localized pressure at one of the light source and light detection regions to stress blood-perfused tissue and partially remove blood from the one of the regions.

31. A method according to claim 30 wherein the step of exerting a localized pressure includes creating a boundary region separating blood-depleted portions of the one of the regions from surrounding blood-perfused portions.

32. A method according to claim 31, further comprising the step of sensing movement of the boundary region.

33. A method of measuring the arterial oxygen saturation level in a patient, comprising the steps of:

physically conforming an arterial oxygen saturation level sensor to a body portion of the patient;

directing light into the body portion at a light source region of the body portion;

detecting light transmitted through the body portion at a light detection region of the body portion;

partially depleting one of the light source and light detection regions of blood and creating a boundary region separating blood-depleted portions of the one of the regions from surrounding blood-perfused portions; and

sensing movement of the boundary region.

34. A method according to claim 33 wherein the step of partially depleting one of the light source and light detection regions of blood includes the step of substantially removing venous blood from the one of the regions.

35. A method according to claim 33 wherein the step of partially depleting one of the light source and light detection regions of blood includes the step of partially removing arterial blood from the one of the regions.

36. A method according to claim 33 wherein the step of partially depleting one of the light source and light detection regions of blood includes the step of exerting a localized pressure on the one of the regions.

37. A method of measuring the arterial oxygen saturation level in a patient, comprising the steps of:

physically conforming an arterial oxygen saturation level sensor to a body portion of the patient;

directing light into the body portion at a light source region of the body portion;

detecting light transmitted through the body portion at a light detection region of the body portion;

substantially eliminating venous pulse effects in one of the light source and light detection regions; and

sensing arterial pulse effects in the one of the regions.

38. A method according to claim 37 wherein the step of substantially eliminating venous pulse effects includes the step of substantially removing venous blood from the one of the regions.

39. A method according to claim 37 wherein the step of substantially eliminating venous pulse effects includes the step of exerting a localized pressure at the one of the regions.

40. A method according to claim 37 wherein the step of sensing arterial pulse effects includes the steps of:

forming a boundary region separating substantially blood-depleted portions from surrounding substantially blood-perfused portions of the one of the regions; and

sensing movement of the boundary region.