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

• US 8,996,090 B2
• Filed: 02/14/2003
• Issued: 03/31/2015
• Est. Priority Date: 06/03/2002
• Status: Active Grant

• Current Assignee: Exostat Medical, Inc. (Vasamed, Inc.)
• Original Assignee: Exostat Medical, Inc. (Vasamed, Inc.)
• Inventors: Anderson, Edward J., Reynolds, Brandon W., Winger, Kent R., Kimball, Victor E.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/366,903
• Publication Number:
  US 20040006263A1
• Time in Patent Office: 4,428 Days
• Field of Search: 600/481, 600/483, 600/485, 600/486, 600500-507, 600/300, 600/301, 600345-366, 600/309
• US Class Current: 600/345
• 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 preventing the application of excessive pressure to a measurement region in tissue comprising:

a probe body having distal and proximal ends, said distal end including a top non-permeable covered portion and a bottom portion defined by a perimeter surface, said perimeter surface defining a recess within said bottom portion;

a single sensor responsive to a quantity of analyte to be measured, the sensor being unobstructedly positioned within the recess wherein the sensor is responsive to analyte concentration through a chemical reaction with a reactant;

wherein in use said top non-permeable covered portion and said perimeter surface create a covered, isolated measurement area within said recess, said recess containing said analyte, which is thereby prevented from dissipating from the measurement area and further wherein the configuration of the perimeter surface and the position of the sensor within the recess allows said analyte measurement to be free of pressure artifact.

2. The device of claim 1, wherein the bottom portion perimeter and recess are adapted to reduce interference from electromagnetic radiation.

3. The device of claim 1, wherein the bottom portion perimeter and recess are adapted to reduce interference from a fluid.

4. The device of claim 3, wherein the fluid is a gas.

5. The device of claim 3, wherein the fluid is a liquid.

6. The device of claim 3, wherein the bottom portion perimeter and recess for preventing analyte from dissipating from the measurement area allows the analyte to come into equilibrium within the measurement area.

7. The device of claim 6, wherein the probe body is sized to fit a nares, mouth, or cheek.

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

9. The device of claim 8 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.

10. The device of claim 1, wherein the physiologic parameter is the concentration 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 10, further comprising an indicating means operably connected to the sensor for indicating analyte concentration in the patient.

13. The device of claim 1, wherein the device further comprises a holding means for immovably securing the device in position.

14. The device of claim 13, wherein the holding means comprises a clip.

15. The device of claim 13, wherein the holding means comprises a handle.

16. The device of claim 13, wherein the holding means is adapted to immovably secure the device without applying a pressure greater than about 1.5×

10⁴ pascals.

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

18. The device of claim 17, wherein the gas is selected from oxygen, carbon dioxide, nitrous oxide, desflurane, enflurane, halothane, isoflurane, methoxyflurane, and sevoflurane.

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

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

21. 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.

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

23. The device of claim 22, wherein the device is adapted for multiple use.

24. The device of claim 23, wherein the sheath has a selectively permeable portion that allows transmission of the analyte therethrough.

25. The device of claim 24, wherein the selectively permeable portion comprises a silicone.

26. The device of claim 24, wherein the selectively permeable portion comprises a porous membrane.

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

28. The device of claim 27, wherein the temperature detecting means is detachable with respect to the device.

29. The device of claim 1, further comprising a sheath covering the probe body.

30. The device of claim 29, wherein the device is adapted for single use.

31. The device of claim 30, wherein the sheath has a selectively permeable portion that allows transmission of the analyte therethrough.

32. The device of claim 31, wherein the selectively permeable portion comprises a silicone.

33. The device of claim 31, wherein the selectively permeable portion comprises a porous membrane.

34. The device of claim 29, wherein the sheath comprises a rigid portion.

35. The device of claim 29, wherein the sheath is disposable.

36. The device of claim 35, wherein the sheath comprises a rigid portion.

37. The device of claim 35, wherein the sheath is disposable.

38. The probe of claim 1 wherein at least a portion of said probe body comprises a material that allows said portion to deform in response to force applied to the device.

39. The device of claim 38, wherein the material comprises a polymer.

40. The device of claim 39, wherein the polymer is selected from the group consisting of polyethylene, polypropylene, polybutylene, polyamide, polyimide, polyester, perfluorinated polymer, polystyrene, poly (vinyl chloride) and elastomers.

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

42. The device of claim 1, 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.

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

44. The device of claim 43, 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.

45. The device of either claim 44, wherein the radiation is ultraviolet, visible, near infrared, or far infrared.

46. The device of either claim 43, wherein the radiation is ultraviolet, visible, near infrared, or far infrared.

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

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 said probe body is constructed to allow the sensor to be secured in the measurement region without relying solely on an adhesive.

50. The device of claim 49, wherein the sensor is detachable with respect to the probe.

51. The device of claim 50, wherein the sensor contains a chemical that changes color in the presence of an analyte associated with the physiologic parameter.

52. The device of claim 1, 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.

53. The device of claim 1 further comprising a clip member coupled to the probe body for immobilizing the device, the clip member having a first portion that extends generally perpendicular from the probe body and a second portion that is generally parallel to the probe body.

54. The device of claim 53, wherein the clip member further comprises a spring mechanism disposed between the first and second portions for preventing application of excessive pressure to the measurement region.

55. The device of claim 53, wherein the second portion of the clip member includes one or more pleats for preventing application of excessive pressure to the measurement region.

56. The device of claim 53, wherein the second portion includes a perforated section for preventing application of excessive pressure to the measurement region.

57. The device of claim 53, wherein the second portion includes an elastically deformable region for preventing application of excessive pressure to the measurement region.

58. The device of claim 1 further comprising a pad positioned on the perimeter of the bottom portion.

59. The device of claim 58, wherein the at least one pad member is formed from a compliant material.

60. The device of claim 59, wherein the compliant material comprises foam.

61. The device of claim 59, wherein the compliant material comprises rubber.

62. A device for preventing the application of excessive pressure to a measurement region in tissue comprising:

a probe body having distal and proximal ends, said distal end including a top non-permeable covered portion and a bottom portion defined by a perimeter surface, said perimeter surface defining a recess within said bottom portion;

a single sensor responsive to a physiologic parameter to be measured, the sensor being unobstructedly positioned within the recess so as not to contact said tissue surface;

wherein in use said top non-permeable covered portion, said perimeter and said recess create a covered, isolated measurement area containing an analyte thereby prevented from dissipating from the measurement area and further wherein a resulting analyte measurement is free of pressure artifact and further wherein the sensor is responsive to analyte concentration through a chemical reaction with a reactant.

63. A device for preventing the application of excessive pressure to a measurement region in tissue comprising:

a probe body having distal and proximal ends, said distal end including a top non-permeable covered portion and a bottom portion defined by a perimeter surface, said perimeter surface defining a recess within said bottom portion;

a single sensor responsive to a physiologic parameter to be measured, the sensor being unobstructedly positioned within the recess; and

a clip member coupled to the probe body for immobilizing the device with respect to the tissue, the clip member having a first portion that extends generally perpendicular from the probe and a second portion that is generally parallel to the probe,

wherein in use said tissue surface said top non-permeable covered portion, said perimeter and said recess create a covered, isolated measurement area containing an analyte thereby prevented from dissipating from the measurement area and further wherein the configuration of the perimeter surface and the position of the sensor within the recess allows said analyte measurement to be free of pressure artifact.