Photoplethysmography Sensors

• US 20140005557A1
• Filed: 10/12/2012
• Published: 01/02/2014
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: Xhale Assurance, Inc. (Koninklijke Philips N.V.), University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: Xhale Assurance, Inc. (Koninklijke Philips N.V.)
• Inventors: Melker, Richard J., Rich, David, Kersey, Andrew, Culen, Matt
• Granted Patent: US 10,390,715 B2
• Time in Patent Office: Days
• US Class Current: 600/479
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0878 using temperature sensing means
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6819 Nose

Abstract

Provided according to embodiments of the invention are photoplethysmography (PPG) sensors, systems and accessories, and methods of making and using the same. In some embodiments of the invention, the PPG sensors include a clip body that includes a first end portion and a second end portion; a flex circuit attached or adjacent to the clip body, and an elastomeric sleeve that envelops (1) at least part of the first end portion and at least part of the flex circuit attached or adjacent thereto; or (2) at least part of the second end portion and at least part of the flex circuit attached or adjacent thereto.

Claims

1. A photoplethysmography (PPG) sensor comprising:

(a) A clip body comprising a first end portion and a second end portion;

(b) a flex circuit attached or adjacent to the clip body, wherein the flex circuit comprises an emitter and a detector; and

(c) an elastomeric sleeve that envelops (1) at least part of the first end portion and at least part of the flex circuit attached or adjacent thereto;

or (2) at least part of the second end portion and at least part of the flex circuit attached or adjacent thereto.

2. The PPG sensor of claim 1, wherein the elastomeric sleeve compressively envelops (1) the at least part of the first end portion and the at least part of the flex circuit attached or adjacent thereto;

or (2) the at least part of the second end portion and the at least part of the flex circuit attached or adjacent thereto.

3. The PPG sensor of claim 1, wherein no adhesive is present between the clip body and the flex circuit, between the clip body and the elastomeric sleeve or between the flex circuit and the elastomeric sleeve.

4. The PPG sensor of claim 1, wherein at least one of the emitter and the detector are enveloped by the elastomeric sleeve.

5. The PPG sensor of claim 1, wherein at least one of the first end portion and the second end portion of the clip body comprises an aperture.

6. The PPG sensor of claim 5, wherein at least one of the emitter and the detector is within or adjacent to the aperture.

7. The PPG sensor of claim 5, wherein the emitter is within or adjacent to an aperture in the first end portion of the clip body, and wherein the detector is within or adjacent to an aperture in the second end portion of the clip body.

8. The PPG sensor of claim 1, wherein the first end portion is configured to secure to an external tissue of a nasal alar, and the second end portion is configured to secure to an internal tissue of the nasal alar.

9. The PPG sensor of claim 8, wherein the clip body generally conforms to the curvature of the nasal tissue secured between the first end portion and the second end portion.

10. The PPG sensor of claim 9, wherein the flex circuit generally conforms to the curvature of the clip body.

11. The PPG sensor of claim 1, wherein the clip body is a flexible molded polymer clip.

12. The PPG sensor of claim 1, wherein the clip body is opaque.

13. The PPG sensor of claim 1, wherein the clip body is substantially U-shaped.

14. The PPG sensor of claim 1, wherein the clip body comprises an aperture in the first end portion and an aperture on the second end portion, and the emitter is within or adjacent to the aperture in the first end portion and the detector is within or adjacent to the aperture in the second end portion.

15. The PPG sensor of claim 14, wherein the sensor comprises a first elastomeric sleeve that envelops a part of the first end portion that comprises the aperture and a part of the flex circuit that comprises the emitter, and further comprises a second elastomeric sleeve that envelops a part of the second end portion that comprises the aperture and a part of the flex circuit that comprises the detector.

16. The PPG sensor of claim 15, wherein the first and second elastomeric sleeves bind the clip body and the flex circuit together, and no adhesive is present between the clip body and the flex circuit, between the clip body and the elastomeric sleeve or between the flex circuit and the elastomeric sleeve.

17. The PPG sensor of claim 1, wherein the elastomeric sleeve comprises at least one elastomer selected from the group consisting of silicone, polyurethane, polyvinyl chloride and styrene-based copolymers.

18. The PPG sensor of claim 1, wherein a surface of the elastomeric sleeve that is configured to contact a body tissue is smooth.

19. The PPG sensor of claim 1, wherein the elastomeric sleeve is substantially transparent.

20. The PPG sensor of claim 1, wherein the elastomeric sleeve comprises an opaque portion and transparent portion.

21. The PPG sensor of claim 20, wherein the elastomeric sleeve is opaque except for a transparent window defined therein.

22. The PPG sensor of claim 1, further comprising a secondary respiration sensor.

23. The PPG sensor of claim 22, wherein the secondary respiration detector comprises a thermistor.

24. The PPG sensor of claim 22, wherein the secondary respiration detector is attached to or part of the flex circuit.

25. The PPG sensor of claim 1, wherein the flex circuit is configured to interface, directly or indirectly, with a signal processing device.

26. The PPG sensor of claim 1, wherein at least part of the first end portion is concave and at least part of the second end portion is convex.

27. A photoplethysmography (PPG) sensor comprising:

a molded polymer clip comprising (a) a first end portion configured to secure onto an external tissue of a nasal alar and (b) a second end portion configured to secure onto an internal tissue of the nasal alar.

28. A system for monitoring a subject, comprising:

a photoplethymography (PPG) sensor that comprises;

(a) a clip body comprising a first end portion and a second end portion;

(b) a flex circuit attached or adjacent to the clip body, wherein the flex circuit comprises an emitter and a detector; and

(c) an elastomeric sleeve that envelops (1) at least part of the first end portion and at least part of the flex circuit attached or adjacent thereto;

or (2) at least part of the second end portion and at least part of the flex circuit attached or adjacent thereto; and

a computer communicatingly connected to the PPG sensor.

29. The system of claim 28, wherein the computer comprises a processing module configured to process PPG signals from the PPG sensor to determine the respiratory rate of the subject.

30. The system of claim 28, wherein the computer comprises a processing module configured to process PPG signals from the PPG sensor to monitor blood flow in the subject.

31. The system of claim 28, wherein the PPG sensor is configured to secure to a nasal alar of the subject.

32. A method of manufacturing a sensor comprising:

inserting an end portion of a sensor body and a part of a flex circuit attached or adjacent to the sensor body into an elastomeric sleeve, wherein the elastomeric sleeve is configured to bind the flex circuit and the sensor body together.

33. The method of claim 32, wherein the flex circuit comprises an electronic component.

34. The method of claim 32, wherein the sensor body comprises a molded clip.

35. The method of claim 34, wherein the sensor body comprises a first end portion and a second end portion, and at least one of the first end portion and the second end portion comprises an aperture, and the electronic component is within or adjacent to the aperture.

36. The method of claim 35, wherein the method comprises inserting the first end portion of the sensor body and a part of a flex circuit attached or adjacent thereto into a first elastomeric sleeve, and inserting a second end portion of the sensor body and a second part of the flex circuit attached or adjacent thereto into a second elastomeric sleeve.

37. The method of claim 32, wherein the flex circuit comprises an emitter and a detector, and the emitter is within or adjacent to an aperture in a first end portion of the sensor body and the detector is within or adjacent to an aperture in a second end portion of the sensor body, and wherein the method comprises inserting the first end portion of the sensor body and the flex circuit attached or adjacent thereto into a first elastomeric sleeve and inserting the second end portion of the sensor body and the flex circuit attached or adjacent thereto into a second elastomeric sleeve.

38. The method of claim 37, wherein the emitter is enveloped within the first elastomeric sleeve and the detector is enveloped within the second elastomeric sleeve.

39. The method of claim 32, wherein the sensor body is flexible and substantially U-shaped.

40. The method of claim 32, wherein the said flex circuit comprises a single electrically conductive layer with all of the electronic components on the same side.

41. The method of claim 32, wherein the flex circuit comprises a moisture protective conformal coating.

42. The method of claim 32, further comprising folding the flex circuit back on itself and securing the fold with adhesive prior to inserting into the sensor body.

43. The method of claim 32, further comprising lubricating the elastomeric sleeve prior to inserting the end portion of the sensor body and the flex circuit attached or adjacent thereto into the elastomeric sleeve.

44. The method of claim 32, further comprising swelling the elastomeric sleeve with a chemical swelling agent prior to inserting the end portion of the sensor body and the flex circuit attached or adjacent thereto into the elastomeric sleeve.

45. The method of claim 32, wherein a surface on the inside of the elastomeric sleeve is smooth.

46. A method of claim 32, wherein the elastomeric sleeve is configured to have an interference fit with the sensor body and flex circuit inserted therein.

47. A method of forming a plethysmography (PPG) sensor, comprising joining a sensor body and a flex circuit, and overmolding a part of the sensor body and a part of the flex circuit attached or adjacent thereto with an elastomeric material to form an elastomeric sleeve that envelops the part of the sensor body and the part of the flex circuit attached or adjacent thereto.

48. An applicator for placing a clip plethysmography (PPG) sensor on a patient comprising:

a device body comprising

a first device arm configured to secure to a first end portion of the PPG sensor; and

a second device arm configured to secure to a second end portion of the PPG sensor;

wherein the device body is configured to separate the first device arm from the second device arm.

49. The device of claim 48, wherein the device body comprises a first class double lever.

50. The device of claim 48, wherein the device is configured such that a part of the first device arm and a part of the second device arm are each independently positioned between the first end portion and the second end portion of the PPG sensor.

51. The device of claim 49, further comprising a first handle portion and a second handle portion, wherein the device is configured such that when the first handle portion and the second handle portion are pressed together, the first device arm and the second device arm separate.

52. The device of claim 51, wherein the device is configured such that when the first device arm and the second device arm separate, the first end portion and the second end portion of the PPG sensor also separate.

53. A kit for PPG monitoring, comprising:

a PPG sensor comprising a clip body; and

an applicator configured to place the PPG sensor onto a subject, wherein the applicator comprises;

a first device arm configured to secure to a first end portion of the PPG sensor; and

a second device arm configured to secure to a second end portion of the PPG sensor;

wherein the device body is configured to separate the first device arm from the second device arm.

54. The kit of claim 53, wherein the PPG sensor is configured to secure to a nasal alar tissue.