Fetal Pulse Oximetry and ECG Sensor

• US 20080221420A1
• Filed: 03/08/2007
• Published: 09/11/2008
• Est. Priority Date: 03/08/2007
• Status: Abandoned Application

• Current Assignee: Nonin Medical Incorporated
• Original Assignee: Nonin Medical Incorporated
• Inventors: Grubac, Vladimir, Isaacson, Philip O., Rosendahl, Peter R., Maser, Douglas R.
• Application Number:
  US11/683,777
• Publication Number:
  US 20080221420A1
• Time in Patent Office: Days
• US Class Current: 600/338
• CPC Class Codes: A61B 2503/02 Foetus
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1464 specially adapted for foetal tissue
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

A medical device configured to be temporarily secured at a tissue field, such as a fetal skull, via a spiral probe. The spiral probe functions to both secure the sensor in place and provide an electrode for ECG purposes. The spiral probe is non-uniform and includes one or more of a stop element, a cross bar element and a collapsed portion adapted to engage tissue after a predetermined rotation of the probe into the tissue field. The probe diameter can expand with an increase in torque applied to a drive rod, leading to disengagement of the drive rod from the probe. The spiral probe and drive rod may define a detent mechanism whereby upon reaching a predetermined torque the drive rod is disengaged from the probe and freely rotates without further entry of the spiral probe into the tissue field.

Claims

1. A sensor device comprising:

a housing carrying a light emitter and a light detector adapted for use in a pulse oximetry process of a tissue field; and

a spiral probe carried by the housing and adapted to secure the housing at the tissue field, wherein an elongated probe driver rotates the spiral probe into engagement with the tissue field, with an end portion of the probe driver extending into the spiral probe during a placement procedure.

2. The sensor device of claim 1 wherein the probe driver rotates the spiral probe relative to the housing.

3. The sensor device of claim 2 wherein the probe driver and a portion of the spiral probe define a detent mechanism which limits a torque transferred to the spiral probe during a placement process.

4. The sensor device of claim 3 wherein the detent mechanism includes a cross bar portion of the spiral probe and a channel on the probe driver which engages the cross bar portion.

5. The sensor device of claim 3 wherein the driver and probe are rotated in a 1:

1 relationship until a collapsed portion of the spiral probe engages the tissue field, with the probe rotating independently from the spiral probe after engagement between the tissue field and the collapsed portion.

6. The sensor device of claim 5 wherein the spiral probe is defined by two or more different diameters.

7. The sensor device of claim 6 wherein a tissue engaging end of the spiral probe has a smaller diameter than an opposite end, and wherein the opposite end engages a conductor to communication thereto a physiologic signal from the tissue field.

8. The sensor device of claim 7 wherein the opposite end of the spiral probe rotates about a ring-shaped surface of the conductor.

9. The sensor device of claim 8 wherein the conductor is defined upon a surface of a flexible circuit, the circuit coupled to a communications link for communicating the physiologic signal to a remote monitor.

10. The sensor device of claim 8 wherein the light emitter and light detector are mounted on a surface of the flexible circuit.

11. The sensor of claim 1 wherein the end portion of the probe driver is received into the spiral probe to a depth determined by a stop, the stop preventing the end portion from being further extended into the spiral probe.

73. A method of using the sensor device of claim 1 comprising:

locating the sensor device proximate to the tissue field;

engaging the tissue field with a sharpened end portion of the spiral probe;

rotating the spiral probe with the probe driver causing the sharpened end to pierce the tissue field;

deforming the spiral probe by further rotation of the probe driver; and

decoupling rotation of the probe driver from the sensor device upon exceeding a predetermined deformation of the spiral probe.

74. The method of claim 73 wherein the deforming causes an increase in a spiral probe diameter.

75. The method of claim 73 wherein the spiral probe is rotated approximately 360 degrees after the tissue field is pierced prior to significant deformation of the probe caused during further rotation.

76. A method of using the sensor device of claim 5, the method resulting in fixation of the sensor device to the tissue field and release of the probe driver from the spiral probe, the method comprising:

locating the sensor device proximate to the tissue field;

engaging the tissue field with a sharpened end portion of the spiral probe; and

rotating the spiral probe with the probe driver until a surface of the tissue field engages the end of the probe driver, wherein further rotation of the probe driver causes the tissue field surface to bias the probe driver away from engagement with the spiral probe, causing the probe driver to be released from the spiral probe.

84. A system comprising:

a sensor device of claim 1, 12, 21, 32, 43 or 54;

a monitor capable of displaying or recording pulse oximeter information and ECG information; and

a communications link between the sensor device and the monitor, said link communicating information from the sensor device to the monitor for display or recording.

85. The medical system of claim 84 wherein the monitor is remotely located.

86. The medical system of claim 84 wherein the communications link includes a wireless component, a wired component or both.

12. A sensor device comprising:

a housing carrying a light emitter and a light detector utilized in a pulse oximetry process; and

a spiral probe carried by the housing and having a tissue engagement portion and a ring engagement portion, with a diameter of the tissue engagement portion being substantially different than a diameter of the ring engagement portion, wherein the tissue engagement portion engages a tissue field and wherein the ring engagement portion engages a conductor to communicate thereto an electrical signal from the tissue field.

13. The sensor device of claim 12 wherein an end portion of an probe driver is inserted into the spiral probe

14. The sensor device of claim 13 wherein the probe driver and a portion of the spiral probe define a detent mechanism which limits a torque transferred to the spiral probe during a placement process.

15. The sensor device of claim 14 wherein the detent mechanism includes a cross bar portion of the spiral probe and a channel on the driver which engages the cross bar portion.

16. The sensor device of claim 14 wherein the driver and probe are rotated in a 1:

1 relationship until a collapsed portion of the spiral probe engages the tissue field, with the probe rotating independently from the spiral probe after engagement between the tissue field and the collapsed portion.

17. The sensor device of claim 12 wherein the ring engagement portion upon a ring-shaped surface of the conductor.

18. The sensor device of claim 17 wherein the conductor is defined upon a surface of a flexible circuit, the circuit coupled to a communications link for communicating the physiologic signal to a remote monitor.

19. The sensor device of claim 18 wherein the light emitter and light detector are mounted on a surface of the flexible circuit.

20. The sensor of claim 13 wherein the end portion of the probe driver is received into the spiral probe to a depth determined by a stop, the stop preventing the end portion from being further extended into the spiral probe.

21. A sensor device comprising:

a housing carrying a light emitter and a light detector utilized in a pulse oximetry process;

a spiral probe carried by the housing; and

a probe driver for rotating the probe, with a distal end of the probe driver being received into the spiral probe to a depth determined by a stop, the stop preventing the driver from being further received into the spiral probe.

22. The sensor device of claim 21 wherein an end portion of the driver extends into the spiral probe.

23. The sensor device of claim 21 wherein the probe driver rotates the spiral probe relative to the housing.

24. The sensor device of claim 21 wherein the probe driver and a portion of the spiral probe define a detent mechanism which limits a torque transferred to the spiral probe during a placement process.

25. The sensor device of claim 24 wherein the detent mechanism includes a cross bar portion of the spiral probe and a channel on the driver which engages the cross bar portion.

26. The sensor device of claim 25 wherein the driver and probe are rotated in a 1:

1 relationship until a collapsed portion of the spiral probe engages a tissue field, with the probe rotating independently from the spiral probe after engagement between the tissue field and the collapsed portion.

27. The sensor device of claim 21 wherein the spiral probe is defined by two or more different diameters.

28. The sensor device of claim 27 wherein a tissue engaging end of the spiral probe has a smaller diameter than an opposite end, and wherein the opposite end engages a conductor to communicate thereto a physiologic signal from a tissue field.

29. The sensor device of claim 28 wherein the opposite end of the spiral probe rotates about a ring-shaped surface of the conductor.

30. The sensor device of claim 29 wherein the conductor is defined upon a surface of a flexible circuit, the circuit coupled to a communications link for communicating the physiologic signal to a remote monitor.

31. The sensor device of claim 30 wherein the light emitter and light detector are mounted on a surface of the flexible circuit.

77. A method of using the sensor device of claim 21 comprising:

locating the sensor device proximate to the tissue field;

engaging the tissue field with a sharpened end of the spiral probe; and

rotating the spiral probe with the probe driver until a surface of the tissue field engages the stop and the end of the probe driver, wherein further rotation of the probe driver causes the tissue field surface to bias the probe driver away from engagement with the stop.

32. A sensor device comprising:

a housing carrying a light emitter and a light detector;

a spiral probe carried by the housing; and

an elongated probe driver for rotating the probe with a 1;

1 relationship into engagement with a tissue field, the spiral probe and driver defining a detent mechanism whereby upon reaching a predetermined torque, the driver rotates without further rotation of the probe into the tissue field.

33. The sensor device of claim 32 wherein an end portion of the driver extends into the spiral probe.

34. The sensor device of claim 33 wherein the probe driver and a portion of the spiral probe define a detent mechanism which limits a torque transferred to the spiral probe during a placement process.

35. The sensor device of claim 34 wherein the detent mechanism includes a cross bar portion of the spiral probe and a channel on the driver which engages the cross bar portion.

36. The sensor device of claim 34 wherein the driver and probe are rotated in the 1:

1 relationship until a collapsed portion of the spiral probe engages the tissue field, with the probe driver rotating independently from the spiral probe after engagement between the tissue field and the collapsed portion.

37. The sensor device of claim 32 wherein the spiral probe is defined by two or more different diameters.

38. The sensor device of claim 37 wherein a tissue engaging end of the spiral probe has a smaller diameter than an opposite end, and wherein the opposite end engages a conductor to communication thereto a physiologic signal from the tissue field.

39. The sensor device of claim 38 wherein the opposite end of the spiral probe rotates about a ring-shaped surface of the conductor.

40. The sensor device of claim 39 wherein the conductor is defined upon a surface of a flexible circuit, the circuit coupled to a communications link for communicating the physiologic signal to a remote monitor.

41. The sensor device of claim 40 wherein the light emitter and light detector are mounted on a surface of the flexible circuit.

42. The sensor of claim 32 wherein the end portion of the probe driver is received into the spiral probe to a depth determined by a stop, the stop preventing the end portion from being further extended into the spiral probe.

78. A method of using the sensor device of claim 32 comprising:

locating the sensor device proximate to the tissue field;

engaging the tissue field with a sharpened end of the spiral probe;

rotating the spiral probe with the probe driver so as to cause a sharpened end to pierce the tissue field; and

continuing to rotate the probe driver until a predetermined torque level is reached, the torque level causing deformation of the spiral probe and release of coupling between the spiral probe and the driver.

79. The method of claim 78 wherein the predetermined torque level is reached subsequent to contact between a collapsed portion of the spiral probe and the tissue field.

80. The method of claim 78 wherein a diameter of the spiral probe increases causing decoupling between the spiral probe and the driver subsequent to contact between a collapsed portion of the spiral probe and the tissue field.

43. A sensor device comprising:

a housing carrying a light emitter and a light detector; and

a spiral probe carried by the housing, the probe being rotatable relative to the housing, with a portion of the probe engaging a tissue field of a patient and another portion of the probe engaging a conductive ring and communicating a physiologic signal from the tissue field.

44. The sensor device of claim 43 wherein an end portion of an probe driver extends into the spiral probe during a placement process.

45. The sensor device of claim 44 wherein the probe driver and a portion of the spiral probe define a detent mechanism which limits a torque transferred to the spiral probe during a placement process.

46. The sensor device of claim 45 wherein the detent mechanism includes a cross bar portion of the spiral probe and a channel on the driver which engages the cross bar portion.

47. The sensor device of claim 44 wherein the driver and probe are rotated in a 1:

1 relationship until a collapsed portion of the spiral probe engages the tissue field, with the driver rotating independently from the spiral probe after engagement between the tissue field and the collapsed portion.

48. The sensor device of claim 43 wherein the spiral probe is defined by two or more different diameters.

49. The sensor device of claim 43 wherein a tissue engaging end of the spiral probe has a smaller diameter than an opposite end, and wherein the opposite end engages a conductor to communicate thereto a physiologic signal from the tissue field.

50. The sensor device of claim 49 wherein the opposite end of the spiral probe rotates about a ring-shaped surface of the conductor.

51. The sensor device of claim 50 wherein the conductor is defined upon a surface of a flexible circuit, the circuit coupled to a communications link for communicating a physiologic signal to a remote monitor.

52. The sensor device of claim 51 wherein the light emitter and light detector are mounted on a surface of the flexible circuit.

53. The sensor of claim 51 wherein an end portion of the probe driver is received into the spiral probe to a depth determined by a stop, the stop preventing the end portion from being further inserted into the spiral probe.

81. A method of using the sensor device of claim 43 comprising:

locating the sensor device proximate to the tissue field;

engaging the tissue field with a sharpened end of the spiral probe;

rotating the spiral probe with the probe driver until the sharpened end reaches a depth within the tissue field; and

deforming the spiral probe by further rotating the probe driver, the deforming resulting in a rotational decoupling between the driver and the spiral probe.

82. The method of claim 81 wherein the deforming results in an increased diameter of at least a portion of the spiral probe which engages a surface of the driver.

54. A sensor device comprising:

a housing carrying a light emitter and a light detector; and

a spiral probe having a sharpened tissue engaging end and an opposite end engaging a conductor for communicating a physiological signal from a tissue field, the spiral probe having a collapsed portion between the tissue engaging end and the opposite end, the spiral probe being rotated to engage a tissue field, with the collapsed portion limiting the depth to which the probe engages the tissue field.

83. A method of using the sensor device of claim 54 comprising:

locating the sensor device proximate to the tissue field;

engaging the tissue field with a sharpened end of the spiral probe; and

rotating the spiral probe with the probe driver until the collapsed portion engages the tissue field, wherein further rotation results in a free spin condition of the probe driver relative to the spiral probe.

55. A sensor device comprising:

a spiral probe having a tissue engaging end;

a light detector receiving light from a light emitter during an oximetry process; and

a flexible circuit, with the spiral probe being in movable contact with the flexible circuit, and the flexible circuit being coupled to a communications link providing communication of a light detector signal and an probe signal to a remote monitor.

56. The sensor device of claim 55 wherein the light detector and light emitter are mounted on a surface of the flexible circuit.

57. The sensor device of claim 55 wherein the spiral probe rotates upon a surface of the flexible circuit.

58. The sensor device of claim 57 wherein the flexible circuit surface is a ring-shaped conductor.

59. The sensor of claim 58 wherein the spiral probe has at least two different diameters, with a smaller diameter at the tissue engaging end.

60. The sensor of claim 59 wherein the spiral probe has at least two different spiral pitches.

61. The sensor of claim 60 wherein the spiral probe includes a collapsed pitch portion.

62. The sensor of claim 60 wherein the spiral probe defines a stop which limits a depth to which the probe can be rotated into a tissue field.

63. The sensor of claim 60 wherein the spiral probe defines a stop which limits a depth to which an end portion of an probe driver can be inserted into the spiral probe.

64. The sensor device of claim 55 wherein an probe driver and a portion of the spiral probe define a detent mechanism which limits a torque transferred to the spiral probe during a placement process.

65. The sensor device of claim 64 wherein the detent mechanism includes a cross bar portion of the spiral probe and a channel on the driver which engages the cross bar portion.

66. The sensor device of claim 65 wherein the driver and probe are rotated in a 1:

1 relationship until a collapsed portion of the spiral probe engages the tissue field, with the driver rotating independently from the spiral probe after engagement between the tissue field and the collapsed portion.

67. A sensor device comprising:

a spiral probe for receiving a physiologic signal from a patient;

a light detector receiving light from a light emitter during an oximetry process of the patient, the light detector being connected to a surface of a flexible circuit; and

a communications link connected to the flexible circuit, the link communicating a signal from the light detector and the physiologic signal from the spiral probe to a remote monitor.

68. The sensor device of claim 67 wherein the spiral probe rotatably engages a conductor defined on a surface of the flexible circuit.

69. The sensor device of claim 68 wherein the spiral probe is defined by multiple different pitches or multiple different diameters or both.

70. The sensor device of claim 67 wherein the spiral probe and an end portion of an probe driver define a detent mechanism which limits a torque transferred to the spiral probe as it engages a tissue field of the patient.

71. The sensor device of claim 67 wherein the spiral probe includes a stop for limiting a depth to which an probe driver end can be inserted into the spiral probe.

72. The sensor device of claim 67 wherein the spiral probe includes a collapsed portion which engages the tissue field during a sensor placement process.