Noninvasive detection of a physiologic parameter within a body tissue of a patient

• US 20040006263A1
• Filed: 02/14/2003
• Published: 01/08/2004
• Est. Priority Date: 06/03/2002
• Status: Active Grant

• Current Assignee: Exostat Medical, Inc. (Vasamed, Inc.)
• Original Assignee: Exostat Medical, Inc. (Vasamed, Inc.)
• Inventors: Kimball, Victor E., Reynolds, Brandon W., Winger, Kent R., Anderson, Edward J.
• Granted Patent: US 8,996,090 B2
• Time in Patent Office: Days
• US Class Current: 600/364
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 2562/247 Hygienic covers, i.e. for covering the sensor or apparatus during use
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

The invention provides a device for contacting a surface of a tissue within a patient'"'"'s body to determine a physiologic parameter of the patient. The device typically comprises a sensor responsive to the physiologic parameter and a probe housing the sensor. The probe is constructed to allow the sensor to be secured at a sensing area adjacent to a surface of a patient'"'"'s tissue, without need for an adhesive and without disturbing the blood flow within the measurement region of the tissue. The device may also include a means for reducing interference in the sensing area. Preferably, the device further comprises an indicating means operably connected to the sensor for indicating an analyte quantity and/or concentration associated with the physiologic parameter. The invention also provides a method for determining a physiologic parameter of a patient.

Claims

1. A device for contacting a surface of a tissue within a patient'"'"'s body to determine a physiologic parameter of the patient, comprising:

a means for preventing application of excessive pressure to the tissue at a measurement region in the tissue upon contact with the device to allow for substantially undisturbed blood flow in the tissue; and

a sensor responsive to the physiologic parameter, wherein the sensor is located within a sensing area adjacent to the measurement region.

2. The device of claim 1, further comprising a means for reducing interference in the sensing area adjacent to the measurement region.

4. The device of claim 2, wherein the means for reducing interference is adapted to reduce interference from a fluid.

5. The device of claim 4, wherein the fluid is a gas.

6. The device of claim 4, wherein the fluid is a liquid.

7. The device of claim 4, wherein the interference reducing means comprises an isolating means for preventing analyte from dissipating from the sensing area and for allowing analyte to come into equilibrium within the sensing area.

8. The device of claim 7, wherein the isolating means represents an integral portion of a probe.

9. The device of claim 7, wherein the isolating means is sized to fit into the nares, mouth, or cheek of the patient.

10. The device of claim 1, wherein the physiologic parameter is the quantity of an analyte.

11. The device of claim 10 wherein the analyte is selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

12. The device of claim 1, wherein the physiologic parameter is the concentration of an analyte.

13. The device of claim 12, wherein the analyte is selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

14. The device of claim 12, further comprising an indicating means operably connected to the sensor for indicating analyte concentration in the patient.

15. The device of claim 1, wherein at least a portion of the device is composed of a material that allows the portion to deform in response to force applied to the device so as to avoid substantial blanching the tissue.

16. The device of claim 15, wherein the material is elastically deformable.

17. The device of claim 15, wherein the material comprises a polymer.

18. The device of claim 17, wherein the polymer is selected from the group consisting of polyethylene, polypropylene, polybutylene, polyamide, polyimide, polyester, perfluorinated polymer, polystyrene, poly (vinyl chloride) and elastomers.

19. The device of claim 1, wherein the device comprises a holding means for securing the device immovably adjacent to the surface of the tissue.

20. The device of claim 19, wherein the holding means comprises a clip.

21. The device of claim 19, wherein the holding means comprises a handle.

22. The device of claim 19, wherein the holding means is adapted to secure the device adjacent to the tissue without applying pressure greater than about 1.5×

10⁴ pascals to the tissue.

23. The device of claim 1, wherein the sensor is responsive to a gas.

24. The device of claim 23, wherein the gas is selected from oxygen, carbon dioxide, nitrous oxide, desflurane, enflurane, halothane, isoflurane, methoxyflurane, and sevoflurane.

25. The device of claim 1, wherein the sensor is responsive to pH.

26. The device of claim 1, wherein the sensor is responsive to blood flow.

27. The device of claim 1, wherein the sensor is responsive to an analyte selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

28. The device of claim 1, further comprising at least one additional sensor.

29. The device of claim 1, wherein the device further comprises a temperature detecting means for detecting temperature at the sensor.

30. The device of claim 29, wherein the temperature detecting means is detachable with respect to the device.

31. The device of claim 1, further comprising a sheath covering the device.

32. The device of claim 31, wherein the device is adapted for single use.

33. The device of claim 32, wherein the sheath has a selectively permeable portion that allows transmission of the analyte therethrough.

34. The device of claim 33, wherein the selectively permeable portion comprises a silicone.

35. The device of claim 33, wherein the selectively permeable portion comprises a porous membrane.

36. The device of claim 31, wherein the sheath comprises a rigid portion.

37. The device of claim 31, wherein the sheath is disposable.

38. The device of claim 28, wherein the device is adapted for multiple use.

39. The device of claim 38, wherein the sheath has a selectively permeable portion that allows transmission of the analyte therethrough.

40. The device of claim 39, wherein the selectively permeable portion comprises a silicone.

41. The device of claim 39, wherein the selectively permeable portion comprises a porous membrane.

42. The device of claim 37, wherein the sheath comprises a rigid portion.

43. The device of claim 37, wherein the sheath is disposable.

44. The device of claim 1, wherein the tissue is nonepidermal.

45. The device of claim 1, wherein the tissue is mucosal.

46. The device of claim 1, wherein the sensor is a Severinghaus-type sensor.

47. The device of claim 1, wherein the sensor is responsive to analyte concentration through a chemical reaction with a reactant.

48. The device of claim 47, wherein the analyte concentration is the concentration of an analyte selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

49. The device of claim 1, wherein the sensor is constructed to be responsive to analyte concentration through absorption, emission or modification of electromagnetic radiation within the tissue.

50. The device of claim 49, wherein the analyte concentration is the concentration of an analyte selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

51. The device of either claim 49, wherein the radiation is ultraviolet, visible, near infrared, or far infrared.

52. The device of either claim 50, wherein the radiation is ultraviolet, visible, near infrared, or far infrared.

53. The device of claim 1, wherein the sensor is responsive to analyte concentration through generation or alteration of an electrical current.

54. The device of claim 53, wherein the analyte concentration is the concentration of an analyte selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

3. The device of clam 2, wherein the means for reducing interference is adapted to reduce interference from electromagnetic radiation.

55. A device for contacting a surface of a tissue within the patient'"'"'s body to determine a physiologic parameter of the patient, comprising:

a means for reducing interference in a sensing area adjacent to a measurement region in the tissue, wherein the means represents an integral portion of a probe; and

a sensor responsive to the physiologic parameter, wherein the sensor is located within the sensing area and within the probe.

56. The device of claim 55, wherein the means for reducing interference is selected to reduce interference from a fluid.

57. The device of claim 56, wherein the fluid is gaseous.

58. The device of claim 56, wherein the fluid is liquid.

59. A device for contacting a surface of a tissue within a patient'"'"'s body to determine a physiologic parameter of the patient, comprising:

a sensor responsive to the physiologic parameter; and

a probe containing the sensor, wherein the probe is constructed to allow the sensor to be secured at a sensing area adjacent to a measurement region in the tissue without relying solely on an adhesive and without substantially disturbing blood flow within the tissue.

60. The device of claim 59, wherein the sensor is detachable with respect to the probe.

61. The device of claim 59, wherein the physiologic parameter is the quantity of an analyte.

62. The device of claim 61, wherein the analyte is selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

63. The device of claim 60, wherein the sensor contains a chemical that changes color in the presence of an analyte associated with the physiologic parameter.

64. A method for determining a physiologic parameter of a patient, the method comprising the steps of:

(a) providing a sensor responsive to the physiologic parameter of a patient;

(b) placing the sensor within a sensing area adjacent to a surface of a measurement region of the patient'"'"'s body tissue without substantially disturbing blood flow within the tissue; and

(c) detecting the response of the sensor to the physiologic parameter.

65. The method of claim 64, further comprising, before step (a), exposing the sensor to an analyte associated with the physiologic parameter at a predetermined concentration in at least one calibrant.

66. The method of claim 65, wherein the analyte is selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

67. The method of claim 64, further comprising, after step (b), exposing the sensor to an analyte associated with the physiologic parameter at a predetermined concentration in at least one calibrant.

68. The method of claim 67, wherein the analyte is selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

69. The method of claim 67, further comprising, after step (b), exposing the sensor to a plurality of analytes associated with the physiologic parameter wherein the plurality of analytes at a predetermined concentration in at least one calibrant.

70. The method of claim 69, wherein the plurality of analytes are selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.

71. The method of claim 64, wherein step (b) comprises allowing the device to contact the surface of the tissue so as to completely or substantially enclose the sensor within the sensing area.

72. The method of claim 71, wherein the sensor is placed in contact with the surface of the tissue.

73. The method of claim 71, wherein the sensor is not placed in contact with the surface of the tissue.

74. The method of claim 71, further comprising, after step (b) and before (c) allowing the concentration of an analyte associated with the physiologic parameter in the sensing area to reach an equilibrium level.

75. The method of claim 71, further comprising, after step (b) and before (c) allowing the concentration of an analyte associated with the physiologic parameter in the tissue at the measurement region to reach an equilibrium level.

76. The method of claim 64, wherein step (b) comprises immobilizing the device with respect to the surface of tissue for a predetermined period.

77. The method of claim 76, wherein step (c) is initiated during the predetermined period of time.

78. The method of claim 76, wherein step (c) is repeated during the predetermined period of time.

79. The method of claim 76, wherein step (c) is performed continuously.

80. The method of claim 64, further comprising (d) correlating the response of the sensor to a condition of the patient.

81. The method of claim 80, wherein the condition is a regional condition.

82. The method of claim 80, wherein the condition is a systemic condition.

83. The method of claim 80, wherein the condition is perfusion failure.

84. The method of claim 80, wherein step (d) is carried out using a predictive algorithm.

85. The method of claim 80, wherein step (d) is carried out using endpoint detection and/or verification.

86. The method of claim 80, wherein step (d) is carried out using univariate, multivariate, or neural network analysis.

87. The method of claim 80, wherein the condition is tissue gas concentration.

88. The method of claim 80, wherein the condition is tissue pH.

89. The method of claim 80, wherein the condition is tissue activity.

90. A method for determining a physiologic parameter of a patient, the method comprising the steps of:

(a) providing a sensor responsive to the physiologic parameter of the patient;

(b) placing the sensor in a sensing area adjacent to the surface of the patient'"'"'s tissue at a measurement region; and

(c) detecting the response of the sensor to the physiologic parameter while preventing interfering fluid ingress into the sensing area.

91. The method of claim 90, further comprising, before step (b), exposing the sensor to an analyte associated with the physiologic parameter at a predetermined concentration in a calibrant.

92. The method of claim 91, further comprising, after step (c), exposing the sensor to an analyte associated with the physiologic parameter at a predetermined concentration in a calibrant

93. The method of claim 90, further comprising, after step (c), exposing the sensor to an analyte associated with the physiologic parameter at a predetermined concentration in a calibrant.

94. The method of claim 93, where the analyte is selected from the group consisting of tissue pH, temperature, CO₂, pCO₂, O₂, glucose, pyruvate, acetyl-CoA, citrate, isocitrate, alpha-ketoglutarate, succinyl-CoA, ADP, ATP, succinate, fumarate, malate oxaloacetate, NAD, NADH, and combinations thereof.