Permanently implantable system and method for detecting, diagnosing and treating congestive heart failure

• US 20030055345A1
• Filed: 10/11/2002
• Published: 03/20/2003
• Est. Priority Date: 01/11/2000
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Eigler, Neal L., Whiting, James S.
• Granted Patent: US 7,137,953 B2
• Time in Patent Office: Days
• US Class Current: 600/486
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

The invention provides improved apparatus and methods for treating congestive heart failure in a medical patient. The apparatus includes a pressure transducer permanently implantable within the left atrium of the patient'"'"'s heart and operable to generate electrical signals indicative of fluid pressures within the patient'"'"'s left atrium. The pressure transducer is connected to a flexible electrical lead, which is connected in turn to electrical circuitry, which in the preferred embodiment includes digital circuitry for processing electrical signals. The electrical circuitry processes the electrical signals from the pressure transducer and, based at least in part on those signals, generates a signal that indicates a desired therapeutic treatment for treating the patient'"'"'s condition. That signal is then communicated to the patient via a patient signaling device, following which the patient administers to him or herself the prescribed therapeutic treatment indicated by the signal.

Claims

1. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:

a pressure transducer operable to generate a signal indicative of fluid pressure within the left atrium;

signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;

a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment;

an implantable housing; and

an implantable flexible cardiac pacing lead, wherein the cardiac pacing lead is combined with a sensor lead providing a signal connection between the pressure transducer and the implantable housing.

2. The apparatus of claim 1, further comprising apparatus configured to anchor the pressure transducer to the patient'"'"'s atrial septum.

3. The apparatus of claim 1, wherein the pressure transducer is located on the cardiac pacing lead a predetermined distance away from a distal tip of the lead, wherein the distance is predetermined so that the pressure transducer will be positioned within the patient'"'"'s left atrium when the distal tip is positioned within a pulmonary vein connected to the patient'"'"'s left atrium.

4. The apparatus of claim 1, further comprising an additional lead, wherein said additional lead is coupled to apparatus configured to anchor the pressure transducer to the patient'"'"'s atrial septum.

5. The apparatus of claim 1, wherein the apparatus configured to anchor the pressure transducer to the patient'"'"'s atrial septum comprises a helical screw configured for advancement into and fixation within the atrial septum.

6. The apparatus of claim 1, wherein the apparatus configured to anchor the pressure transducer to the patient'"'"'s atrial septum comprises at least one anchor deployable by spring force.

7. The apparatus of claim 1, wherein at least one component of the apparatus for treating congestive heart failure is at least partially contained within the housing.

8. The apparatus of claim 1, further comprising apparatus configured to anchor the pressure transducer to the patient'"'"'s atrial septum.

9. The apparatus of claim 1 wherein the signal processing apparatus includes an analog-to-digital converter operable to convert analog signals from the pressure transducer to digital data reflective of the fluid pressure within the left atrium.

10. The apparatus of claim 1, wherein the signal processing apparatus includes digital memory for storing data reflective of pressures within the left atrium.

11. The apparatus of claim 10, further comprising apparatus configured to retrieve the data reflective of pressures within the left atrium from the digital memory.

12. The apparatus of claim 11, wherein the data retrieval apparatus includes a transceiver operable to transmit the data through the patient'"'"'s skin.

13. The apparatus of claim 1, wherein the signal processing apparatus is operable to receive modified programming with the signal processing apparatus implanted within the patient'"'"'s body.

14. The apparatus of claim 1, wherein the patient signaling device includes apparatus configured to produce an electrical shock perceptible by the patient.

15. The apparatus of claim 1, wherein the patient signaling device is operable to generate at least four distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment.

16. The apparatus of claim 1, wherein the patient signaling device is operable to transmit at least one message through the patient'"'"'s skin to a remote device.

17. The apparatus of claim 16, wherein the patient signaling device is operable to provide written or visual instructions to the patient.

18. The apparatus of claim 16, wherein said remote device is a hand held device.

19. The apparatus of claim 16, wherein said remote device is a tabletop display.

20. The apparatus of claim 1, wherein the patient signaling device is operable to transmit at least one message through the patient'"'"'s skin to a device for generating spoken instructions to the patient.

21. The apparatus of claim 20, wherein said spoken instructions to the patient comprise instructions regarding a responsive action to be performed by the patient.

22. The apparatus of claim 20, wherein said spoken instructions to the patient comprise therapeutic instructions.

23. The apparatus of claim 22 wherein said therapeutic instructions comprise instructions regarding the patient'"'"'s medication.

24. The apparatus of claim 20, wherein the spoken instructions comprise synthesized speech.

25. The apparatus of claim 20, wherein the spoken instructions comprise a recorded voice.

26. The apparatus of claim 25, wherein the recorded voice comprises the actual recorded voice of the patient'"'"'s physician.

27. An apparatus according to claim 1, wherein the transducer is situated within the left atrium.

28. An apparatus according to claim 1, wherein the transducer is situated within a pulmonary vein.

29. An apparatus according to claim 1, wherein the transducer is situated within the left atrial appendage.

30. An apparatus according to claim 1, wherein the transducer is located in the septal wall.

31. An apparatus according to claim 1, wherein the transducer is situated at a location within the heart having a pressure that is at least nearly the same as the pressure in the left atrium.

32. An apparatus according to claim 1, wherein the transducer is situated at a location within the heart sufficient to generate a signal indicative of fluid pressure within the left atrium.

33. An apparatus according to claim 1, wherein the transducer is situated at a location outside the heart sufficient to generate a signal indicative of fluid pressure within the left atrium.

34. An apparatus according to claim 1, wherein the transducer is situated at a location relative to the heart sufficient to generate a signal indicative of fluid pressure within the left atrium.

35. An apparatus according to claim 1, wherein the transducer is associated with the heart in a manner that is sufficient to generate a signal indicative of fluid pressure within the left atrium.

36. The apparatus of claim 1, further comprising a second sensor in addition to the pressure transducer, the second sensor operable to generate a second signal indicative of a second condition within the body of the patient, wherein the signal processing apparatus is operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the second signal generated by the second sensor.

37. The apparatus of claim 36, wherein the second sensor is a second pressure transducer.

38. The apparatus of claim 36, wherein the second sensor is an ECG electrode.

39. The apparatus of claim 36, wherein the second sensor is configured for implantation in the patient'"'"'s right atrium.

40. The apparatus of claim 36, wherein the second sensor is configured for implantation in a location inside the patient'"'"'s body outside the atria.

41. The apparatus of claim 1, wherein the patient signaling device includes a mechanical vibrator operable to produce a vibration perceptible by the patient.

42. The apparatus of claim 1, wherein the patient signaling device includes a transmitter operable to send information to a remote receiver.

43. The apparatus of claim 1, wherein the signal processing apparatus includes power management circuitry operable to deny power to at least some portions of the signal processing apparatus during periods of relative inactivity between periods of device operation.

44. The apparatus of claim 1, wherein the signal processing apparatus includes apparatus operable to compute mean left atrial pressures based on multiple individual signals generated by the pressure transducer.

45. The apparatus of claim 1, wherein the patient signaling device is operable to generate at least one signal indicative of an appropriate therapeutic treatment comprising a reduction in the normal dose of at least one medication taken by the patient.

46. The apparatus of claim 1, wherein the patient signal device generates signals in the form of predetermined sequences of individual signal pulses, the signal pulses being perceptible by the patient.

47. A method for treating congestive heart failure in a medical patient, the method comprising:

implanting a cardiac pacing lead combined with a sensor lead connected to a pressure transducer substantially permanently within the medical patient;

operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;

communicating the signal indicative of the fluid pressure within the left atrium to a signal processing apparatus;

operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein operating the signal processing apparatus includes generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment; and

communicating the signal indicative of the appropriate therapeutic treatment to the patient.

48. The method of claim 47, and further comprising implanting at least a portion of the signal processing apparatus substantially permanently within the patient'"'"'s body.

49. The method of claim 47, and further comprising anchoring the pressure transducer to the patient'"'"'s atrial septum.

50. The method of claim 49, wherein implanting the signal processing apparatus within the patient'"'"'s body includes implanting the signal processing apparatus in a subcutaneous pocket in the region of the patient'"'"'s shoulder.

51. The method of claim 49, wherein anchoring the pressure transducer to the patient'"'"'s atrial septum comprises advancing a helical screw into the patient'"'"'s atrial septum.

52. The method of claim 49, wherein anchoring the pressure transducer to the patient'"'"'s atrial septum comprises deploying at least one anchor by spring force to bear against the patient'"'"'s atrial septum.

53. The method of claim 47, wherein communicating the signal indicative of the appropriate therapeutic treatment includes generating an electrical shock perceptible by the patient.

54. The method of claim 47, wherein generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment, includes generating one of at least four distinct signals.

55. The method of claim 47, wherein generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment, comprises transmitting at least one message through the patient'"'"'s skin to a remote device.

56. The method of claim 55, further comprising providing written or visual instructions to the patient.

57. The method of claim 55, wherein said remote device is a hand held device.

58. The method of claim 55, wherein said remote device is a tabletop display.

59. The method of claim 47, wherein generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment, comprises transmitting at least one message through the patient'"'"'s skin to a device for generating spoken instructions to the patient.

60. The method of claim 59, wherein said spoken instructions to the patient comprise instructions regarding a responsive action to be performed by the patient.

61. The method of claim 59, wherein said spoken instructions to the patient comprise therapeutic instructions.

62. The method of claim 61, wherein said therapeutic instructions comprise instructions regarding the patient'"'"'s medication.

63. The method of claim 59, wherein the spoken instructions comprise synthesized speech.

64. The method of claim 59, wherein the spoken instructions comprise a recorded voice.

65. The method of claim 64, wherein said recorded voice comprises the actual recorded voice of the patient'"'"'s physician.

66. The method of claim 47, wherein the step of implanting a cardiac pacing lead combined with a pressure transducer substantially permanently within the medical patient further comprises implanting said cardiac pacing lead combined with a pressure transducer substantially permanently within the medical patient in a location selected from the group consisting of:

the left atrium, a pulmonary vein, the left atrial appendage and the septal wall.

67. The method of claim 47, wherein implanting the cardiac pacing lead combined with the pressure transducer within the medical patient comprises:

approaching the left atrium through the right atrium;

penetrating the patient'"'"'s atrial septum; and

positioning the pressure transducer inside the patient'"'"'s left atrium.

68. The method of claim 67, and further comprising approaching the right atrium through the superior vena cava.

69. The method of claim 67, and further comprising approaching the right atrium through the inferior vena cava.

70. The method of claim 47, wherein implanting the cardiac pacing lead combined with the pressure transducer substantially permanently within the medical patient includes advancing the cardiac pacing lead partially into a pulmonary vein connected to the left atrium while positioning the pressure transducer within the left atrium.

71. The method of claim 47, wherein implanting the pressure transducer substantially permanently within the medical patient includes:

advancing a first lead component carrying anchoring apparatus to the left atrium and deploying the anchoring apparatus to anchor the first lead component to the patient'"'"'s atrial septum; and

advancing a cardiac pacing lead combined with a pressure transducer along the first lead component until the cardiac pacing lead is in a position wherein the pressure transducer is positioned within the patient'"'"'s left atrium.

72. The method of claim 47, wherein communicating the signal indicative of the appropriate therapeutic treatment includes operating a mechanical vibrator to produce a vibration perceptible by the patient.

73. The method of claim 47, wherein communicating the signal indicative of the appropriate therapeutic treatment includes operating a transmitter to send information to a remote receiver.

74. The method of claim 47, further comprising operating power management circuitry to deny power to at least some portions of the signal processing apparatus during periods of relative inactivity between periods of active operation of those portions of the signal processing apparatus.

75. The method of claim 47, wherein operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment includes computing mean left atrial pressures based on multiple individual signals generated by the pressure transducer.

76. The method of claim 47, wherein operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment includes generating a signal indicative of an appropriate therapeutic treatment comprising a reduction in the normal dose of at least one medication taken by the patient.

77. The method of claim 47, wherein communicating the signal indicative of the appropriate therapeutic treatment to the patient includes communicating to the patient at least one predetermined sequence comprising multiple individual signal pulses perceptible by the patient.

78. The method of claim 47, wherein operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment includes diagnosing a cause of worsening CHF.

79. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:

indicator means for generating a signal indicative of fluid pressure within the left atrium;

signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the indicator means;

a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment; and

an implantable cardiac pacing lead, wherein the cardiac pacing lead is combined with the indicator means.

80. An apparatus according to claim 79, wherein the indicator means is a pressure transducer.

81. A apparatus according to claim 79, wherein the indicator means is situated within the left atrium.

82. An apparatus according to claim 79, wherein the indicator means is situated within a pulmonary vein.

83. An apparatus according to claim 79, wherein the indicator means is situated within the left atrial appendage.

84. An apparatus according to claim 79, wherein the indicator means is located in the septal wall.

85. An apparatus according to claim 79, wherein the indicator means is situated at a location within the heart having a pressure that is at least nearly the same as the pressure in the left atrium.

86. An apparatus according to claim 79, wherein the indicator means is situated at a location within the heart sufficient to generate a signal indicative of fluid pressure within the left atrium.

87. An apparatus according to claim 79, wherein the indicator means is situated at a location outside the heart sufficient to generate a signal indicative of fluid pressure within the left atrium.

88. An apparatus according to claim 79, wherein the indicator means is situated at a location relative to the heart sufficient to generate a signal indicative of fluid pressure within the left atrium.

89. An apparatus according to claim 79, wherein the indicator means is associated with the heart in a manner that is sufficient to generate a signal indicative of fluid pressure within the left atrium.

90. The apparatus of claim 79, wherein the cardiac pacing lead provides a signal connection between the indicator means and the signal processing apparatus.

91. The apparatus of claim 79, further comprising apparatus configured to anchor the indicator means to the patient'"'"'s atrial septum.

92. The apparatus of claim 79, wherein the indicator means is located on the cardiac pacing lead a predetermined distance away from a distal tip of the lead, wherein the distance is predetermined so that the indicator means will be positioned within the patient'"'"'s left atrium when the distal tip is positioned within a pulmonary vein connected to the patient'"'"'s left atrium.

93. The apparatus of claim 79, further comprising an additional lead coupled to apparatus configured to anchor the cardiac pacing lead to the patient'"'"'s atrial septum.

94. The apparatus of claim 79, further comprising apparatus configured to anchor the indicator means to the patient'"'"'s atrial septum.

95. The apparatus of claim 91, wherein the apparatus configured to anchor the indicator means to the patient'"'"'s atrial septum comprises a helical screw configured for advancement into and fixation within the atrial septum.

96. The apparatus of claim 94, wherein the apparatus configured to anchor the indicator means to the patient'"'"'s atrial septum comprises at least one anchor deployable by spring force.

97. The apparatus of claim 79, wherein the signal processing apparatus includes an analog-to-digital converter operable to convert analog signals from the indicator means to digital data reflective of the fluid pressure within the left atrium.

98. The apparatus of claim 79, wherein the signal processing apparatus includes digital memory for storing data reflective of pressures within the left atrium.

99. The apparatus of claim 98, further comprising apparatus configured to retrieve the data reflective of pressures within the left atrium from the digital memory.

100. The apparatus of claim 99, wherein the data retrieval apparatus includes a transceiver operable to transmit the data through the patient'"'"'s skin.

101. The apparatus of claim 79, wherein the signal processing apparatus is operable to receive modified programming with the signal processing apparatus implanted within the patient'"'"'s body.

102. The apparatus of claim 79, wherein the patient signaling device includes a mechanical vibrator operable to produce a vibration perceptible by the patient.

103. The apparatus of claim 79, wherein the patient signaling device includes apparatus configured to produce an electrical shock perceptible by the patient.

104. The apparatus of claim 79, wherein the patient signaling device is operable to generate at least four distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment.

105. The apparatus of claim 79, wherein the patient signal device generates signals in the form of predetermined sequences of individual signal pulses, the signal pulses being perceptible by the patient.

106. The apparatus of claim 79, further comprising a second sensor in addition to the indicator means, the second sensor operable to generate a second signal indicative of a second condition within the body of the patient, wherein the signal processing apparatus is operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the second signal generated by the second sends.

107. The apparatus of claim 79, wherein the patient signaling device includes a transmitter operable to send information to remote receiver.

108. The apparatus of claim 79, wherein the signal processing apparatus includes power management circuitry operable to deny power to at least some portions of the signal processing apparatus during periods of relative inactivity between periods of device operation.

109. The apparatus of claim 79, wherein the signal processing apparatus includes apparatus operable to compute mean left atrial pressures based on multiple individual signals generated by the indicator means.

110. The apparatus of claim 79, wherein the patient signaling device is operable to generate at least one signal indicative of an appropriate therapeutic treatment comprising a reduction in the normal dose of at least one medication taken by the patient.

111. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:

a pressure transducer operable to generate a signal indicative of fluid pressure within the medical patient;

signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;

a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment; and

an implantable flexible sensor lead providing a signal connection between the pressure transducer and the signal processing apparatus; and

an implantable cardiac pacing lead.

112. The apparatus of claim 111, wherein the pressure transducer is located on the flexible sensor lead.

113. The apparatus of claim 112, wherein at least one component of the apparatus is at least partially contained within a housing, the housing configured for permanent implantation within the patient'"'"'s body.

114. A method for treating congestive heart failure in a medical patient, the method comprising:

implanting a flexible sensor lead coupled to a pressure transducer substantially permanently within the medical patient;

implanting a cardiac pacing lead to run substantially parallel to said flexible lead;

operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;

communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;

operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein operating the signal processing apparatus includes generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment; and

communicating the signal indicative of the appropriate therapeutic treatment to the patient.

115. The method of claim 114, wherein at least one of the, the pressure transducer, or the signal processing apparatus is at least partially contained within a housing, the housing configured for permanent implantation within the patient'"'"'s body.

116. The method of claim 114, wherein the step of implanting a flexible lead coupled to a pressure transducer substantially permanently within the medical patient further comprises implanting said flexible lead substantially permanently in a location selected from the group consisting of:

the left atrium, a pulmonary vein, the left atrial appendage, and the atrial septal wall.

117. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:

a pressure transducer operable to generate a signal indicative of fluid pressure within the medical patient;

signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;

a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment;

an implantable housing; and

an implantable flexible defibrillator lead, wherein the defibrillator lead is combined with a sensor lead providing a signal connection between the pressure transducer and the implantable housing.

118. An apparatus according to claim 117, wherein the transducer is situated within the left atrium.

119. An apparatus according to claim 117, wherein the transducer is situated within a pulmonary vein.

120. An apparatus according to claim 117, wherein the transducer is situated within the left atrial appendage.

121. An apparatus according to claim 117, wherein the transducer is located in the septal wall.

122. A method for treating congestive heart failure in a medical patient, the method comprising:

implanting a defibrillator lead combined with a sensor lead connected to a pressure transducer substantially permanently within the medical patient;

operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;

communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;

operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein operating the signal processing apparatus includes generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment; and

communicating the signal indicative of the appropriate therapeutic treatment to the patient.

123. The method of claim 122, wherein at least one of the defibrillator lead, the pressure transducer or the signal processing apparatus is at least partially contained within the housing.

124. The method of claim 122, wherein the step of implanting a defibrillator lead combined with a pressure transducer substantially permanently within the medical patient further comprises implanting said defibrillator lead combined with a pressure transducer substantially permanently in a location selected from the group consisting of:

the left atrium, a pulmonary vein, the left atrial appendage and the septal wall.

125. Apparatus for treating congestive heart failure in a medical patient, the apparatus comprising:

a pressure transducer operable to generate a signal indicative of fluid pressure within the medical patient;

signal processing apparatus operable to generate a signal indicative of an appropriate therapeutic treatment based at least in part on the signal generated by the pressure transducer;

a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient, wherein the patient signaling device is operable to generate at least two distinct signals distinguishable from one another by the patient, each said signal indicative of a different therapeutic treatment; and

an implantable flexible lead providing a signal connection between the pressure transducer and the signal processing apparatus; and

an implantable defibrillator lead.

126. An apparatus according to claim 125, wherein the transducer is situated within the left atrium.

127. An apparatus according to claim 125, wherein the transducer is situated within a pulmonary vein.

128. An apparatus according to claim 125, wherein the transducer is situated within the left atrial appendage.

129. An apparatus according to claim 125, wherein the transducer is located in the septal wall.

130. A method for treating congestive heart failure in a medical patient, the method comprising:

implanting a flexible lead coupled to a pressure transducer substantially permanently within the medical patient;

implanting a defibrillator lead to run substantially parallel to said flexible lead;

operating the pressure transducer to generate a signal indicative of fluid pressure within the left atrium;

communicating the signal indicative of the fluid pressure within the left atrium to signal processing apparatus;

operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment, wherein operating the signal processing apparatus includes generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment; and

communicating the signal indicative of the appropriate therapeutic treatment to the patient.

131. The method of claim 130, wherein at least one of the defibrillator lead, the pressure transducer or the signal processing apparatus is at least partially contained within a housing, the housing configured for permanent implantation within the patient'"'"'s body.

132. The method of claim 130, wherein the step of implanting a flexible lead coupled to a pressure transducer substantially permanently within the medical patient further comprises implanting said flexible lead coupled to a pressure transducer substantially permanently in a location selected from the group consisting of:

the left atrium, a pulmonary vein, the left atrial appendage and the septal wall.