Tonometry system for determining blood pressure

• US 5,158,091 A
• Filed: 11/30/1990
• Issued: 10/27/1992
• Est. Priority Date: 11/30/1990
• Status: Expired due to Term

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Ivax Corporation (Teva Pharmaceutical Industries, Ltd.)
• Inventors: Butterfield, Robert D., Martin, Stephen A., Holdaway, Charles R., Pytel, Kenneth J.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Pontius, Kevin
• Application Number:
  US07/621,165
• Time in Patent Office: 697 Days
• Field of Search: 128/687-690, 128/633, 128/634, 128/748, 128/672
• US Class Current: 600/485
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02422 within occluders
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal

Abstract

A tissue contact stress sensing system incorporates a semiconductor assembly and a continuous diaphragm to noninvasively determine the intra-arterial blood pressure of a patient. The system comprises a continuous diaphragm placed against a patient'"'"'s tissue which covers an underlying artery. The semiconductor assembly is placed in close proximity to and spaced apart from the diaphragm for directly irradiating the diaphragm with electromagnetic radiation and receiving a portion of the electromagnetic radiation which is reflected from the continuous diaphragm. The disclosed system also utilizes a technique for minimizing the system errors associated with temperature drift and aging of the sensor.

Claims

1. For use in a system for noninvasively determining the intra-arterial blood pressure of a patient, a tissue contact stress sensing apparatus comprising:

a wafer having a continuous diaphragm for placing against a patient'"'"'s tissue which covers an underlying artery, said diaphragm adapted to be deformed in response to stress in said tissue caused by the intra-arterial blood pressure of said artery,

semiconductor assembly means placed in close proximity to and spaced apart from said continuous diaphragm for directly,

irradiating said diaphragm with electromagnetic radiation,

receiving a portion of said electromagnetic radiation reflected from said continuous diaphragm, and

whereby the quantity of electromagnetic radiation received by said semiconductor assembly means is a function of the displacement of said continuous diaphragm in response to said tissue stress caused by said intra-arterial blood pressure of said artery.

2. The tissue contact stress sensing apparatus of claim 1 wherein said diaphragm is comprised of silicon.

3. The tissue contact stress sensing apparatus of claim 2, wherein said diaphragm is comprised of single crystal silicon.

4. The tissue contact stress sensing apparatus of claim 2, wherein said wafer is comprised of silicon and has a longitudinal trough therein and, wherein the bottom of said trough forms one side of said diaphragm.

5. The tissue contact stress sensing apparatus of claim 4, wherein said longitudinal trough has a cross-sectional profile generally resembling a tetragonal-pyramidal geometry.

6. The tissue contact stress sensing apparatus of claim 4, wherein said trough has a generally planar bottom.

7. The tissue contact stress sensing apparatus of claim 1, wherein said wafer has a longitudinal trough therein and, wherein the bottom of said trough forms one side of said diaphragm, and wherein said trough bottom is coated with a reflective material for reflecting the electromagnetic radiation irradiated by said semiconductor assembly means.

8. The tissue contact stress sensing apparatus of claim 7, wherein said trough bottom is generally 6.5×

10^-6 meters thick.

9. The tissue contact stress sensing apparatus of claim 7, wherein said trough bottom is coated with metal.

10. The tissue contact stress sensing apparatus of claim 9, wherein said metal is selected from the group consisting of gold or aluminum.

11. The tissue contact stress sensing apparatus of claim 9, wherein said metal coating is generally 600 angstroms thick.

12. The tissue contact stress sensing apparatus of claim 1, wherein said diaphragm has an effective stiffness which is sufficient to prevent significant distortion of the stress information contained within the received electromagnetic radiation.

13. The tissue contact stress sensing apparatus of claim 1, wherein said continuous diaphragm has a strain rate of generally 0.24 micro-inch/mmHg.

14. The tissue contact stress sensing apparatus of claim 1, wherein said diaphragm has two opposing longitudinal sides spaced generally 0.020 inches apart.

15. The tissue contact stress sensing apparatus of claim 1, wherein said wafer has a generally rectangular face for placing against said tissue overlying said artery, said face having a first and second set of opposing parallel sides, wherein said first set of opposing sides of said rectangular face are generally 0.577 inches apart, and wherein said diaphragm is bounded by at least two generally parallel sides spaced generally 0.425 inches apart.

16. The tissue contact stress sensing apparatus of claim 15, wherein said second set of opposing parallel sides of said face are generally 0.200 inches apart.

17. The tissue contact stress sensing apparatus of claim 1 further including a spacer element disposed between said wafer and said semiconductor assembly means and wherein said spacer element, diaphragm, wafer and semiconductor assembly means all have a substantially similar thermal expansion coefficient for minimizing thermally induced drift and offset errors.

18. The tissue contact stress sensing apparatus of claim 17, wherein said spacing element is comprised of silicon nitride.

19. The tissue contact stress sensing apparatus of claim 1, wherein said semiconductor assembly means is comprised of a plurality of emitters for irradiating said diaphragm with electromagnetic radiation, and a plurality of detectors each having an output, each detector receiving a portion of said electromagnetic radiation and transducing said received radiation into a respectively associated electronic current output signal.

20. The tissue contact stress sensing apparatus of claim 19, wherein said continuous diaphragm is generally planar having a rectangular boundary, said boundary having an opposing pair of long sides and an opposing pair of short sides.

21. The tissue contact stress sensing apparatus of claim 20, wherein said plurality of emitters are arranged generally in a row which is generally parallel to and spaced apart from one of said long sides of said diaphragm, and wherein said detectors are arranged generally in a row separate from said row of emitters, and generally parallel to and spaced apart from one of said long sides of said diaphragm.

22. The tissue contact stress sensing apparatus of claim 21, wherein said emitters are generally equally spaced apart from one another and said detectors are generally equally spaced apart from one another, and wherein said row of emitters is juxtaposed to said row of detectors such that any two adjacent detectors in said row of detectors lie equidistant from at least one common emitter in said row of emitters.

23. The tissue contact stress sensing apparatus of claim 19, wherein each emitter in said plurality of emitters irradiates electromagnetic radiation in a beam field which when projected onto said diaphragm, overlaps the projected beam field of its closest adjacent neighbors.

24. The tissue contact stress sensing apparatus of claim 19, wherein said electromagnetic radiation is selected from the group consisting of visible, infrared and ultraviolet light.

25. The tissue contact stress sensing apparatus of claim 19, further comprising converter means, coupled to the outputs of said detectors, for converting said electric current signal output by each detector into an electric voltage signal.

26. The tissue contact stress sensing apparatus of claim 25, further comprising multiplexing means and central processing means, said multiplexing means coupled to said converter means for selecting one of said converted electronic signals and transferring said signal to said central processing means for analysis.

27. The tissue contact stress sensing apparatus of claim 1, wherein said semiconductor assembly means includes a portion for irradiating electromagnetic radiation onto and detecting electromagnetic radiation reflected from a reference surface, said reference surface spaced apart from said diaphragm.

28. The tissue contact stress sensing apparatus of claim 27, wherein said semiconductor assembly means and said portion of said semiconductor assembly means are fabricated from substantially the same materials and reside in close proximity to each other.

29. The tissue contact stress sensing apparatus of claim 28, wherein said electromagnetic radiation is selected from the group consisting of visible, infrared and ultraviolet light.

30. For use in a system for noninvasively determining the intra-arterial blood pressure of a patient, a tissue contact stress sensor for generating a tissue contact stress signal indicative of said intra-arterial blood pressure and a correction signal for compensating for errors in said tissue contact stress signal caused by temperature drift and aging of said sensor, said system comprising:

a wafer having a continuous diaphragm and a nonresponsive portion, said continuous diaphragm for placing against a patient'"'"'s tissue which covers an underlying artery, said diaphragm adapted to be deformed in response to said intra-arterial blood pressure of said artery,

semiconductor assembly means spaced apart from and placed in close proximity to said continuous diaphragm for directly,

irradiating said diaphragm with electromagnetic radiation,

receiving a portion of said electromagnetic radiation reflected from said continuous diaphragm,

converting said received radiation into a tissue contact stress signal which represents blood pressure data whereby the quantity of electromagnetic radiation which is received by said semiconductor assembly means is a function of the displacement experienced by said continuous diaphragm in response to said intra-arterial blood pressure of said artery,

spacing structure coupled to said nonresponsive portion of said wafer and said semiconductor assembly means, said spacing structure fixing said separation between said semiconductor assembly means and said wafer,

a portion of said semiconductor assembly means, spaced apart from and placed in close proximity to said nonresponsive portion of said wafer for directly,

irradiating said nonresponsive portion of said wafer with electromagnetic radiation,

receiving a portion of said electromagnetic radiation reflected from said nonresponsive portion of said wafer,

converting said received radiation into a correction signal which represents reference data which is indicative of at least one reference factor, and

whereby any change in the radiation received by said portion of said semiconductor assembly means is attributed to at least one of said reference factors and whereby said correction signal is combined with said tissue contact stress signal in a manner which minimizes the dependence of said blood pressure data on at least one of said reference factors.

31. The tissue contact stress sensor of claim 30, wherein said reference factors include temperature and aging of said wafer, semiconductor assembly means and spacing structure.

32. The tissue contact stress sensor of claim 30, wherein said semiconductor assembly means and said portion of said semiconductor assembly means are fabricated from substantially the same materials and at substantially the same time and said materials reside in close proximity to each other.

33. The tissue contact stress sensor of claim 30, wherein said diaphragm is comprised of single crystal silicon.

34. The tissue contact stress sensor of claim 33, wherein said spacing structure is comprised of silicon nitride.

35. The tissue contact stress sensor of claim 30, wherein said electromagnetic radiation is selected from the group consisting of visible, infrared, and ultraviolet light.

36. The tissue contact stress sensor of claim 30, wherein said diaphragm is comprised of a silicon base having a longitudinal trough therein.

37. The tissue contact stress sensor of claim 36, wherein said trough has a generally planar bottom.

38. The tissue contact stress sensor of claim 37, wherein said trough bottom is generally 6.5×

10^-6 meters thick.

39. A method for correcting errors in the output signal of a tissue contact stress sensor, said errors caused by the effects of aging and environmental factors on said sensor, said tissue contact stress sensor of the type having an element for placing against a patient'"'"'s tissue covering an artery of interest, said element responsive to tissue stress, comprising the steps of:

constructing a tissue contact stress sensor and a reference sensor from substantially identical materials at substantially the same time,

adapting said tissue contact stress sensor to be responsive to said element,

adapting said reference sensor to be responsive to a fixed reference source which does not vary with said tissue contact stress measured by said tissue contact stress sensor, whereby an output signal of said reference sensor only changes as a function of said reference sensor aging, temperature and environmental factors,

adapting said tissue contact stress sensor and said reference sensor to share the same environment so as to be equally influenced by aging and environmental factors, and

combining the output signals generated by said tissue contact stress sensor and said reference sensor in a way which removes said influence of aging and environmental factors from said output of said tissue contact stress sensor.

40. For use in a system for noninvasively determining the intra-arterial blood pressure of a patient, a miniaturized tissue contact stress sensing apparatus comprising:

a silicon wafer having a nonresponsive portion and a continuous silicon diaphragm portion, said continuous silicon diaphragm portion for placing against a patient'"'"'s tissue which covers an underlying artery, said diaphragm adapted to be responsive to stress in said tissue caused by blood pressure pulsations in said underlying artery,

integrated circuit means placed in close proximity to and spaced apart from said continuous diaphragm for directly,

irradiating said diaphragm with electromagnetic radiation,

receiving a portion of said electromagnetic radiation reflected from said continuous diaphragm, and

whereby the quantity of electromagnetic radiation received by said integrated circuit means is a function of the tissue stress sensed by said continuous diaphragm, said tissue stress resulting from blood pressure pulsations in said underlying artery.

41. The tissue contact stress sensing apparatus of claim 40, wherein said diaphragm is comprised of single crystal silicon.

42. The tissue contact stress sensing apparatus of claim 40, wherein said wafer has a longitudinal trough therein and wherein the bottom of said trough forms one side of said diaphragm and wherein said longitudinal trough has a cross-sectional profile generally resembling a tetragonal-pyramidal geometry.

43. The tissue contact stress sensing apparatus of claim 42, wherein said trough has a generally planar bottom and wherein said trough bottom is coated with a material for reflecting the electromagnetic radiation irradiated by said integrated circuit means.

44. The tissue contact stress sensing apparatus of claim 43, wherein said trough bottom is generally 6.5×

10^-6 meters thick.

45. The tissue contact stress sensing apparatus of claim 43, wherein said trough bottom is coated with metal and wherein said metal is selected from the group consisting of gold or aluminum and wherein said metal coating is generally 600 angstroms thick.

46. The tissue contact stress sensing apparatus of claim 40, wherein said diaphragm has an effective stiffness of generally fifty times greater than that typical of said tissue over laying said artery.

47. The tissue contact stress sensing apparatus of claim 40, wherein said continuous diaphragm has a strain rate of generally 0.24 micro-inch/mmHg.

48. The tissue contact stress sensing apparatus of claim 40, wherein said diaphragm has two opposing longitudinal sides spaced generally 0.020 inches apart.

49. The tissue contact stress sensing apparatus of claim 40, wherein said wafer has a generally rectangular face for placing against said tissue overlying said artery, said face having a first and second set of opposing parallel sides, wherein said first set of opposing sides of said rectangular face are generally 0.577 inches apart, and wherein said diaphragm is bounded by at least two generally parallel sides spaced generally 0.425 inches apart and wherein said second set of opposing parallel sides of said face are generally 0.200 inches apart.

50. The tissue contact stress sensing apparatus of claim 40, further including a spacing element disposed between said continuous diaphragm and said integrated circuit means for providing alignment and positioning of said integrated circuit means in relation to said diaphragm and wherein said spacing element has a thermal expansion coefficient substantially similar to that of said continuous diaphragm and wherein said spacing element is comprised of silicon nitride.

51. The tissue contact stress sensing apparatus of claim 40, wherein said integrated circuit means is comprised of a plurality of emitters for irradiating said diaphragm with electromagnetic radiation, and a plurality of detectors each having an output, each detector receiving a portion of said electromagnetic radiation and transducing said received radiation into a respectively associated electric current output signal.

52. The tissue contact stress sensing apparatus of claim 51, wherein said continuous diaphragm is generally planar having a rectangular boundary, said boundary having an opposing pair of long sides and an opposing pair of short sides and wherein said plurality of emitters are arranged generally in a row which is generally parallel to and spaced apart from one of said long sides of said diaphragm, and wherein said detectors are arranged generally in a row separate from said row of emitters, and generally parallel to and spaced apart from one of said long sides of said diaphragm.

53. The tissue contact stress sensing apparatus of claim 52, wherein said emitters are generally equally spaced apart and said detectors are generally equally spaced apart, and wherein said row of emitters is juxtaposed to said row of detectors such that any two adjacent detectors in said row of detectors lie equidistant from at least one common emitter in said row of emitters.

54. The tissue contact stress sensing apparatus of claim 51, wherein each emitter in said plurality of emitters irradiates electromagnetic radiation in a beam field which when projected onto said diaphragm, overlaps the projected beam field of its closest adjacent neighbors.

55. The tissue contact stress sensing apparatus of claim 51, wherein each emitter radiates electromagnetic energy which follows a Lambertian pattern about an axis normal to an emitting surface of said emitter and wherein said electromagnetic radiation is selected from the group consisting of visible, infrared and ultraviolet light.

56. The tissue contact stress sensing apparatus of claim 51, further comprising converter means coupled to the outputs of said detectors for converting said electric current signal output by each detector into and electric voltage signal and further comprising multiplexing means and central processing means said multiplexing means coupled to said converter means for selecting one of said converted electronic signals and transferring said signal to said central processing means for processing.

57. The tissue contact stress sensing apparatus of claim 40, wherein said integrated circuit means further includes a referencing portion for irradiating electromagnetic radiation onto and detecting electromagnetic radiation reflected from a surface of said nonresponsive portion of said silicon wafer, said nonresponsive wafer surface spaced apart from said diaphragm and wherein said integrated circuit means and said referencing portion of said integrated circuit means are fabricated from substantially the same materials and reside in close proximity to each other and wherein said electromagnetic radiation is selected from the group consisting of visible, infrared and ultraviolet light.