Device and method to measure and communicate body parameters

• US 20020052563A1
• Filed: 07/20/2001
• Published: 05/02/2002
• Est. Priority Date: 09/03/1997
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Nagavarapu, Sudha, Penn, Richard D., Roline, Glenn M., Christopherson, Mark A., Stylos, Lee, Miesel, Keith Alan
• Granted Patent: US 6,731,976 B2
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/02154 by optical transmission
• CPC Class Codes: A61B 5/031 Intracranial pressure
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6864 Burr holes
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

A device and method for measuring and communicating parameters of a brain, tissue or other organs is disclosed. The invention includes a sensor to sense the parameter of interest. The sensor is preferably located at the distal end of a probe. In the preferred embodiment, the sensor is part of a passive system that allows pressure or temperature measurements to be made and communicated to an attending practitioner when the passive system receives power from an external source. In an alternate embodiment, the sensor is part of a system having a long-term energy source and storage system that allows pressure or temperature measurements to be taken periodically or upon demand, stored and then communicated to an attending practitioner as desired. The invention also includes, in one embodiment, a method for measuring and communicating parameters of a brain, tissue or other organs. The method includes the steps of providing a sensor to sense the parameter of interest, implanting the sensor in or near a target in the brain, tissue or other organ where the parameter of interest may be sensed, providing a reaction device where the parameter may be displayed, processed or cause action to be taken, sensing the parameter or interest, communicating the sensed parameter to the reaction device and displaying or processing the parameter or causing action to be taken in response to the parameter.

Claims

1. A device for measuring and communicating parameters of a brain, tissue or other organs comprising:

a sensor to sense the parameter of interest;

an external device where the parameter may be displayed, processed or cause action to be taken;

a communication system to communicate the sensed parameter from the sensor to the external device.

2. The device of claim 1 wherein the parameter of interest is chosen from the group consisting of intracranial pressure, CSF pressure or temperature.

3. The device of claim 1 wherein the sensor is a pressure sensor.

4. The device of claim 1 wherein the sensor is a temperature sensor.

5. The device of claim 1 wherein the sensor is chosen from a group consisting of a partial oxygen pressure (PO₂) sensor, mixed venous oxygen saturation (SVO₂) sensor, blood glucose sensor and pH sensor.

6. The device of claim 1 further comprising a probe and wherein the probe includes the sensor.

7. The device of claim 6 wherein the probe has a distal end and wherein the sensor is located at the distal end of the probe.

8. The device of claim 6 wherein the probe has a long-term energy source for powering itself and the sensor.

9. The device of claim 8 wherein the long-term energy source is rechargeable.

10. The device of claim 8 wherein the long-term energy source is a battery.

11. The device of claim 8 wherein the long-term energy source is a capacitor.

12. The device of claim 6 wherein the probe has a storage system that stores sensed parameter information.

13. The device of claim 6 wherein the sensor is electronically connected to the probe through a body bus.

14. The device of claim 6 wherein the probe includes a microprocessor.

15. The device of claim 6 wherein calibration coefficients, unique to each sensor, are stored in the storage device for the purpose of post-measurement processing to achieve an accurate report of the physiological parameters measured by the sensor.

16. The device of claim 6 further comprising a probe head located at the proximal end of the probe.

17. The device of claim 16 wherein the probe head is roughly discoid in shape.

18. The device of claim 16 wherein the probe head includes an embedded probe coil.

19. The device of claim 18 wherein the probe coil is an inductive coil.

20. The device of claim 6 wherein the probe includes an electronics case containing probe electronics.

21. The device of claim 20 wherein the probe includes a body between the sensor and the electronics case.

22. The device of claim 6 wherein the probe has a periphery and wherein the probe has screw threads placed around the periphery of the probe.

23. The device of claim 6 further comprising a burr-hole ring having an opening and wherein the probe is placed in the opening of the burr-hole ring.

24. The device of claim 1 further comprising a passive power system that provides power to the sensor to allow parameter information to be sensed by the sensor.

25. The device of claim 1 wherein the communication system includes a portion associated with and connected to the sensor and further comprising a passive power system for providing power to the portion of the communication system associated with and connected to the sensor for communicating parameter information sensed by the sensor to the external device.

26. The device of claim 1 further comprising a CSF shunt or drainage system having a catheter placed in the ventricles of the brain, a shunt used as a conduit to transport CSF from one location in the body to another and a pump located between the catheter and the shunt wherein the pump operates in response to the sensed parameter of interest by the sensor.

27. The device of claim 1 further comprising a CSF shunt or drainage system having a catheter placed in the ventricles of the brain, a shunt used as a conduit to transport CSF from one location in the body to another and a valve located between the catheter and the shunt wherein the valve operates in response to the sensed parameter of interest by the sensor.

28. The device of claim 1 wherein calibration coefficients, unique to each sensor, are stored in the external device for the purpose of post-measurement processing to achieve an accurate report of the physiological parameters measured by the sensor.

29. The device of claim 1 wherein calibration coefficients, unique to each sensor, are stored in the sensor for the purpose of post-measurement processing to achieve an accurate report of the physiological parameters measured by the sensor.

30. The device of claim 1 further comprising a storage device and wherein calibration coefficients, unique to each sensor, are stored in the storage device for the purpose of post-measurement processing to achieve an accurate report of the physiological parameters measured by the sensor.

31. The device of claim 1 wherein the communication system includes a display system that displays or otherwise communicates the sensed parameter information to a user.

32. The device of claim 31 wherein the display system includes a display screen that displays the sensed parameter information to the physician or other user.

33. The device of claim 1 wherein the communication system is connected to an external computer.

34. The device of claim 1 wherein the communication system includes an alarm that activates to alert the user when the sensed parameter is outside of a pre-determined range.

35. The device of claim 1 wherein the external device includes a barometer to measure the atmospheric pressure.

37. The device of claim 36 wherein the sensor is a pressure sensor.

38. The device of claim 36 wherein the sensor is a temperature sensor.

39. The device of claim 36 wherein the sensor is chosen from a group consisting of a partial oxygen pressure (PO₂) sensor, mixed venous oxygen saturation (SVO₂) sensor, blood glucose sensor and pH sensor.

40. The device of claim 36 wherein the sensor is separated from the probe.

41. The device of claim 40 wherein the sensor is electronically connected to the probe through a body bus.

42. The device of claim 36 wherein the probe includes a microprocessor.

43. The device of claim 36 wherein the probe has a long-term energy source for powering itself and the sensor.

44. The device of claim 43 wherein the long-term energy source is rechargeable.

45. The device of claim 43 wherein the long-term energy source is a battery.

46. The device of claim 43 wherein the long-term energy source is a capacitor.

47. The device of claim 36 wherein the probe has a storage system that stores sensed parameter information.

48. The device of claim 47 wherein calibration coefficients, unique to each sensor, are stored in the storage device for the purpose of post-measurement processing to achieve an accurate report of the physiological parameters measured by the sensor.

49. The device of claim 36 further comprising a passive power system that provides power to the probe to allow parameter information to be sensed by the sensor and to allow the sensed parameter information to be communicated to the external device.

50. The device of claim 36 further comprising a CSF shunt or drainage system having a catheter placed in the ventricles of the brain, a shunt used as a conduit to transport CSF from one location in the body to another and a pump located between the catheter and the shunt wherein the pump operates in response to the sensed parameter of interest by the sensor.

51. The device of claim 36 further comprising a CSF shunt or drainage system having a catheter placed in the ventricles of the brain, a shunt used as a conduit to transport CSF from one location in the body to another and a valve located between the catheter and the shunt wherein the valve operates in response to the sensed parameter of interest by the sensor.

52. The device of claim 36 wherein calibration coefficients, unique to each sensor, are stored in the external device for the purpose of post-measurement processing to achieve an accurate report of the physiological parameters measured by the sensor.

53. The device of claim 36 wherein calibration coefficients, unique to each sensor, are stored in the probe for the purpose of post-measurement processing to achieve an accurate report of the physiological parameters measured by the sensor.

54. The device of claim 36 further comprising a probe head located at the proximal end of the probe.

55. The device of claim 54 wherein the probe head is roughly discoid in shape.

56. The device of claim 54 wherein the probe head includes an embedded probe coil.

57. The device of claim 56 wherein the probe coil is an inductive coil.

58. The device of claim 36 wherein the probe includes an electronics case containing the probe electronics.

59. The device of claim 58 wherein the probe includes a body between the sensor and the electronics case.

60. The device of claim 36 wherein the probe has a periphery and wherein the probe has screw threads placed around the periphery of the probe.

61. The device of claim 36 further comprising a burr-hole ring having an opening and wherein the probe is placed in the opening of the burr-hole ring.

36. A device for measuring and communicating parameters of a brain, tissue or other organs comprising:

an implanted probe having a distal end and a proximal end and a sensor located at the distal end of the probe to sense the parameter of the brain, tissue or other organs;

an external device where the parameter may be displayed, processed or cause action to be taken;

a communication system to communicate the sensed parameter from the sensor to the external device.

62. A device for controlling a medical device in response to a sensed parameter of a brain comprising:

a CSF shunt drainage system including a drainage catheter, adaptable to be placed in a patient'"'"'s ventricle, a control device connected to the drainage catheter and a drainage bag, connected to the control device, wherein the control device affects the flow of CSF fluid from a patient'"'"'s ventricle to the drainage bag;

an implanted probe having a distal end and a proximal end and a sensor located at the distal end of the probe to sense the parameter of the brain, tissue or other organs, the probe including a processing system for processing sensed parameter information to produce a control signal that activates or inactivates the control device.

63. The device of claim 62 wherein the control device is a pump and wherein the pump, when activated, moves CSF fluid from the patient'"'"'s ventricle to the drainage bag.

64. The device of claim 62 wherein the control device is a valve that, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

65. A device for controlling a medical device in response to a sensed parameter of a brain comprising:

a CSF shunt drainage system including a first catheter, adaptable to be placed in a patient'"'"'s ventricle, a control device connected to the first catheter and a second catheter, adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity and connected to the control device, wherein the control device affects the flow of CSF fluid from a patient'"'"'s ventricle to the second catheter; and

an implanted probe having a distal end and a proximal end and a sensor located at the distal end of the probe to sense the parameter of the brain, tissue or other organs, the probe including a processing system for processing sensed parameter information to produce a control signal that activates or inactivates the control device.

66. The device of claim 65 wherein the control device is a pump and wherein the pump, when activated, moves CSF fluid from the patient'"'"'s ventricle to the drainage bag.

67. The device of claim 65 wherein the control device is a valve that, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

69. The device of claim 68 wherein the control device is a pump and wherein the pump, when activated, moves CSF fluid from the patient'"'"'s ventricle to the drainage bag.

70. The device of claim 68 wherein the control device is a valve that, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

68. A device for controlling a medical device in response to a sensed parameter of a brain comprising:

a CSF shunt drainage system including a drainage catheter, adaptable to be placed in a patient'"'"'s ventricle, a control device connected to the drainage catheter, the control device including a processing system for processing sensed parameter information to produce a control signal that activates or inactivates the control device and a drainage bag, connected to the control device, wherein the control device affects the flow of CSF fluid from a patient'"'"'s ventricle to the drainage bag;

an implanted probe having a distal end and a proximal end and a sensor located at the distal end of the probe to sense the parameter of the brain, tissue or other organs.

71. A device for controlling a medical device in response to a sensed parameter of a brain comprising:

a CSF shunt drainage system including a first catheter, adaptable to be placed in a patient'"'"'s ventricle, a second catheter, adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity and a control device connected to the first catheter, the control device including a processing system for processing sensed parameter information to produce a control signal that activates or inactivates the control device and connected to the control device, wherein the control device affects the flow of CSF fluid from a patient'"'"'s ventricle to the second catheter; and

an implanted probe having a distal end and a proximal end and a sensor located at the distal end of the probe to sense the parameter of the brain, tissue or other organs;

72. The device of claim 71 wherein the control device is a pump and wherein the pump, when activated, moves CSF fluid from the patient'"'"'s ventricle to the drainage bag.

73. The device of claim 71 wherein the control device is a valve that, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

74. A device for controlling a medical device in response to a sensed parameter of a brain comprising:

a CSF shunt drainage system including a drainage catheter, adaptable to be placed in a patient'"'"'s ventricle, a control device connected to the drainage catheter and a drainage bag, connected to the control device, wherein the control device affects the flow of CSF fluid from a patient'"'"'s ventricle to the drainage bag;

an implanted probe having a distal end and a proximal end and a sensor located at the distal end of the probe to sense the parameter of the brain, tissue or other organs;

an external device including a processing system for processing sensed parameter information to produce a control signal that activates or inactivates the control device; and

a communication system to communicate the sensed parameter from the sensor to the external device and from the external device to the control device.

75. The device of claim 74 wherein the control device is a pump and wherein the pump, when activated, moves CSF fluid from the patient'"'"'s ventricle to the drainage bag.

76. The device of claim 74 wherein the control device is a valve that, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

77. A device for controlling a medical device in response to a sensed parameter of a brain comprising:

a CSF shunt drainage system including a first catheter, adaptable to be placed in a patient'"'"'s ventricle, a control device connected to the first catheter and a second catheter, adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity and connected to the control device, wherein the control device affects the flow of CSF fluid from a patient'"'"'s ventricle to the second catheter;

an implanted probe having a distal end and a proximal end and a sensor located at the distal end of the probe to sense the parameter of the brain, tissue or other organs;

an external device including a processing system for processing sensed parameter information to produce a control signal that activates or inactivates the control device; and

a communication system to communicate the sensed parameter from the sensor to the external device and from the external device to the control device.

78. The device of claim 77 wherein the control device is a pump and wherein the pump, when activated, moves CSF fluid from the patient'"'"'s ventricle to the drainage bag.

79. The device of claim 77 wherein the control device is a valve that, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

80. A method of measuring a parameter of the brain, such as CSF fluid pressure, comprising the steps of:

providing a probe having a sensor to sense the parameter of interest;

providing an external device where the parameter may be displayed, processed or cause action to be taken;

providing a communication system to communicate the sensed parameter from the probe to the external device;

exposing the skull of a patient;

drilling a hole in the skull;

implanting the probe so that the sensor is located within the skull;

closing the patient'"'"'s skin so that the probe is entirely contained under the patient'"'"'s skin;

bringing the external device near the probe so that the sensed parameter is transferred from the probe to the external device.

81. The method of claim 80 wherein the step of providing an external device includes the step of providing a system for providing power to the probe.

82. The method of claim 80 further comprising the step of storing sensed pressure or temperature information from the sensor on the probe to be transmitted to the external device at a later time.

83. The method of claim 80 wherein the step of providing a probe includes the step of providing a long term power source to provide power to the probe.

84. The method of claim 80 wherein the probe includes a microprocessor.

85. The method of claim 80 further comprising the step of controlling a CSF shunt drainage system in response to the sensed parameter.

86. A method of controlling a CSF shunt drainage system comprising the steps of:

providing a probe having a sensor to sense a parameter of interest;

providing a CSF shunt drainage system including a control device to affect the flow of CSF fluid from a patient'"'"'s ventricle to the CSF shunt drainage system;

implanting the probe so that the sensor is located in the patient'"'"'s ventricle;

sensing the patient'"'"'s CSF fluid pressure;

activating the control device in response to the sensed parameter.

87. The method of claim 86 wherein the step of providing a CSF shunt drainage system includes the step of providing a drainage catheter, adaptable to be placed in a patient'"'"'s ventricle, coupled to the control device and a drainage bag also coupled to the control device.

88. The method of claim 86 wherein the step of providing a CSF shunt drainage system includes the step of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, coupled to the control device and a second catheter adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity.

89. The method of claim 86 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a drainage bag and wherein the control device is a pump coupled to the first catheter and the drainage bag, which pump, when activated, moves CSF fluid from a patient'"'"'s ventricle to the drainage bag.

90. The method of claim 86 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a second catheter adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity and wherein the control device is a pump coupled to the first and second catheters, which pump, when activated, moves CSF fluid from a patient'"'"'s ventricle to the patient'"'"'s atrium or peritoneal cavity.

91. The method of claim 86 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a drainage bag and wherein the control device is a valve coupled to the first catheter and the drainage bag, which valve, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

92. The method of claim 86 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a second catheter adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity and wherein the control device is a valve coupled to the first and second catheters, which valve, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the patient'"'"'s atrium or peritoneal cavity.

93. The method of claim 86 wherein the control device is a pump.

94. The method of claim 86 wherein the control device is a valve.

95. The method of claim 86 wherein the control device is connected to a microprocessor so that the microprocessor controls the control device.

96. The method of claim 86 wherein the step of activating the control device in response to the sensed parameter includes the step of determining that the CSF pressure exceeds a predetermined level and thereafter activating the control device.

97. The method of claim 96 wherein the step of activating the control device in response to the sensed parameter includes the step of determining that the CSF pressure has fallen to an acceptable level and thereafter de-activating the control device.

98. The method of claim 86 wherein the step of implanting the probe so that the sensor is located at a desired location in a patient includes the step of placing the sensor in or in contact with the parenchyma or ventricles of the brain where pressure or temperature information may be sensed.

99. The method of claim 86 wherein the step of implanting the probe so that the sensor is located at a desired location in a patient includes the step of placing the sensor in contact with or in the spinal column, organs of the body such as the liver, kidneys, the heart, the bladder, tumors or growths, body tissue, joints, cavities, sinuses or spaces between organs or tissue.

100. A method of controlling a medical device in response to a sensed parameter comprising the steps of:

providing a probe having a sensor to sense a parameter of interest;

providing a medical device having a control device that acts in response to the sensed parameter of interest to control the operation of the medical device;

implanting the probe so that the sensor is located at a desired location in a patient;

sensing the parameter of interest;

activating the control device in response to the sensed parameter.

101. The method of claim 100 wherein the step of providing a CSF shunt drainage system includes the step of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, coupled to the control device and a second catheter adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity.

102. The method of claim 100 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a drainage bag and wherein the control device is a pump coupled to the first catheter and the drainage bag, which pump, when activated, moves CSF fluid from a patient'"'"'s ventricle to the drainage bag.

103. The method of claim 100 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a second catheter adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity and wherein the control device is a pump coupled to the first and second catheters, which pump, when activated, moves CSF fluid from a patient'"'"'s ventricle to the patient'"'"'s atrium or peritoneal cavity.

104. The method of claim 100 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a drainage bag and wherein the control device is a valve coupled to the first catheter and the drainage bag, which valve, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the drainage bag.

105. The method of claim 100 wherein the step of providing a CSF shunt drainage system includes the steps of providing a first catheter, adaptable to be placed in a patient'"'"'s ventricle, and providing a second catheter adaptable to be placed in a patient'"'"'s atrium or peritoneal cavity and wherein the control device is a valve coupled to the first and second catheters, which valve, when activated, allows CSF fluid to move from a patient'"'"'s ventricle to the patient'"'"'s atrium or peritoneal cavity.

106. The method of claim 105 wherein the control device is a pump.

107. The method of claim 105 wherein the control device is a valve.

108. The method of claim 105 wherein the control device is connected to a microprocessor so that the microprocessor controls the control device.

109. The method of claim 105 wherein the step of activating the control device in response to the sensed parameter includes the step of determining that the sensed parameter is outside predetermined limits and thereafter activating the control device.

110. The method of claim 105 wherein the step of activating the control device in response to the sensed parameter includes the step of determining that the parameter of interest is within predetermined limits and thereafter deactivating the control device.

111. The method of claim 105 wherein the step of implanting the probe so that the sensor is located at a desired location in a patient includes the step of placing the sensor in or in contact with the parenchyma or ventricles of the brain where pressure or temperature information may be sensed.

112. The method of claim 105 wherein the step of implanting the probe so that the sensor is located at a desired location in a patient includes the step of placing the sensor in contact with or in the spinal column, organs of the body such as the liver, kidneys, the heart, the bladder, tumors or growths, body tissue, joints, cavities, sinuses or spaces between organs or tissue.