Systems and methods for detecting, diagnosing and treating congestive heart failure

• US 7,115,095 B2
• Filed: 04/19/2002
• Issued: 10/03/2006
• Est. Priority Date: 01/11/2000
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/127,227
• Publication Number:
  US 20030055344A1
• Time in Patent Office: 1,628 Days
• Field of Search: 600483-486, 600/488, 600/508, 600/481, 607/23, 607 17- 20, 607/9, 607/14, 607/24, 607 2- 6, 607/30, 607/32
• 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. A method for treating congestive heart failure in a medical patient, the method comprising:

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment, wherein

operating the signal processing apparatus comprises generating one of at least two distinct instructive signals, each said signal indicative of a different therapeutic treatment; and

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

2. The method of claim 1, further comprising implanting at least a portion of the signal processing apparatus substantially permanently within the patient'"'"'s body.

3. The method of claim 1, further comprising anchoring the pressure transducer to the patient'"'"'s atrial septum.

4. The method of claim 2, wherein implanting the signal processing apparatus within the patient'"'"'s body comprises implanting the signal processing apparatus in a subcutaneous pocket in the region of the patient'"'"'s shoulder.

5. The method of claim 3, wherein anchoring the pressure transducer to the patient'"'"'s atrial septum comprises advancing a helical screw into the patient'"'"'s atrial septum.

6. The method of claim 3, 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.

7. The method of claim 1, further comprising implanting the signal processing apparatus within the patient'"'"'s body.

8. The method of claim 1, wherein communicating the instructive signal indicative of the appropriate therapeutic treatment comprises generating an electrical shock perceptible by the patient.

9. The method of claim 1, wherein generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment, camprises generating one of at least four distinct signals.

10. The method of claim 1, wherein the transducer is situated within the left atrium.

11. The method of claim 1, wherein the transducer is situated within a pulmonary vein.

12. The method of claim 1, wherein the transducer is situated within the left atrial appendage.

13. The method of claim 1, wherein the transducer is located in the septal wall.

14. The method of 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.

15. The method of claim 1, wherein the transducer is situated within the heart.

16. The method of claim 1, wherein the transducer is situated outside of the heart.

17. The method of 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.

18. The method of claim 1, wherein implanting a pressure transducer comprises:

approaching the left atrium of the patient'"'"'s heart through the right atrium;

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

positioning the pressure transducer in pressure sensing contact with the patient'"'"'s left atrium.

19. The method of claim 18, further comprising approaching the right atrium through the superior vena cava.

20. The method of claim 18, further comprising approaching the right atrium through the inferior vena cava.

21. The method of claim 1, wherein implanting the pressure transducer within the medical patient comprises advancing a flexible lead carrying the pressure transducer partially into a pulmonary vein connected to the left atrium while positioning the pressure transducer within the left atrium.

22. The method of claim 1, wherein implanting the pressure transducer within the medical patient comprises:

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 second lead component carrying a pressure transducer along the first lead component until the second lead component is in a position wherein the pressure transducer is positioned within the patient'"'"'s left atrium.

23. The method of claim 1, wherein communicating the instructive signal indicative of the appropriate therapeutic treatment comprises operating a mechanical vibrator to produce a vibration perceptible by the patient.

24. The method of claim 1, wherein communicating the instructive signal indicative of the appropriate therapeutic treatment comprises operating a transmitter to send information to a remote receiver.

25. The method of claim 1, 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.

26. The method of claim 1, wherein operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment comprises computing mean left atrial pressures based on multiple individual signals generated by the pressure transducer.

27. The method of claim 1, wherein operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment comprises 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.

28. The method of claim 1, wherein communicating the instructive signal indicative of the appropriate therapeutic treatment to the patient comprises communicating to the patient at least one predetermined sequence comprising multiple individual signal pulses perceptible by the patient.

29. The method of claim 1, wherein operating wherein operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment comprises diagnosing a cause of worsening CHF.

30. The method of claim 1, 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.

31. The method of claim 30, further comprising providing written or visual instructions to the patient.

32. The method of claim 30 wherein said remote device is a hand held device.

33. The method of claim 30, wherein said remote device is a tabletop display.

34. The method of claim 1, 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.

35. The method of claim 34, wherein said spoken instructions to the patient comprise instructions regarding a responsive action to be performed by the patient.

36. The method of claim 34, wherein said spoken instructions to the patient comprise therapeutic instructions.

37. The method of claim 36, wherein said therapeutic instructions comprise instructions regarding the patient'"'"'s medication.

38. The method of claim 34, wherein the spoken instructions comprise synthesized speech.

39. The method of claim 34, wherein the spoken instructions comprise a recorded voice.

40. The method of claim 39, wherein said recorded voice comprises the actual recorded voice of the patient'"'"'s physician.

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

implanting a pressure transducer within the medical patient, wherein implanting 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 in pressure sensing contact with the patient'"'"'s left atrium;

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 an instructive signal indicative of an appropriate therapeutic treatment; and

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

42. The method of claim 41, further comprising approaching the right atrium through the superior vena cava.

43. The method of claim 41, further comprising approaching the right atrium through the inferior vena cava.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment;

communicating the instructive signal indicative of the appropriate therapeutic treatment to the patient; and

anchoring the pressure transducer to the patients atrial septum, by advancing a helical screw into the patient'"'"'s atrial septum.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment;

communicating the instructive signal indicative of the appropriate therapeutic treatment to the patient; and

deploying at least one anchor by spring force to bear against the patient'"'"'s atrial septum, thereby anchoring the pressure transducer to the patient'"'"'s atrial septum.

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

implanting a pressure transducer within the medical patient, wherein said implanting comprises;

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 second lead component carrying a pressure transducer along the first lead component until the second lead

component is in a position wherein the pressure transducer is positioned in pressure sensing contact with the patient'"'"'s left atrium;

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 an instructive signal indicative of an appropriate therapeutic treatment; and

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

47. The method of claim 46, wherein the transducer is situated within the left atrium.

48. The method of claim 46, wherein the transducer is situated within a pulmonary vein.

49. The method of claim 46, wherein the transducer is situated within the left atrial appendage.

50. The method of claim 46, wherein the transducer is located in the septal wall.

51. The method of claim 46, 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.

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

implanting a pressure transducer within the medical patient;

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

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

operating the signal processing apparatus to generate an instructive signal indicative of an appropriate therapeutic treatment; and

communicating the instructive signal indicative of the appropriate therapeutic treatment to the patient, wherein said communicating comprises operating a mechanical vibrator to produce a vibration perceptible by the patient.

53. The method of claim 52, wherein the transducer is situated within the left atrium.

54. The method of claim 52, wherein the transducer is situated within a pulmonary vein.

55. The method of claim 52, wherein the transducer is situated within the left atrial appendage.

56. The method of claim 52, wherein the transducer is located in the septal wall.

57. The method of claim 52, 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.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment; and

communicating the instructive signal indicative of the appropriate therapeutic treatment to the patient, wherein said communicating comprises operating a transmitter to send information to a remote receiver.

59. The method of claim 58, wherein the transducer is situated within the left atrium.

60. The method of claim 58, wherein the transducer is situated within a pulmonary vein.

61. The method of claim 58, wherein the transducer is situated within the left atrial appendage.

62. The method of claim 58, wherein the transducer is located in the septal wall.

63. The method of claim 58, 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.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment;

communicating the instructive signal indicative of the appropriate therapeutic treatment to the patient; and

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.

65. The method of claim 64, wherein the transducer is situated within the left atrium.

66. The method of claim 64, wherein the transducer is situated within a pulmonary vein.

67. The method of claim 64, wherein the transducer is situated within the left atrial appendage.

68. The method of claim 64, wherein the transducer is located in the septal wall.

69. The method of claim 64, 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.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatments wherein said operating comprises computing mean left atrial pressures based on multiple individual signals generated by the pressure transducer; and

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

71. The method of claim 70, wherein the transducer is situated within the left atrium.

72. The method of claim 70, wherein the transducer is situated within a pulmonary vein.

73. The method of claim 70, wherein the transducer is situated within the left atrial appendage.

74. The method of claim 70, wherein the transducer is located in the septal wall.

75. The method of claim 70, 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.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment, wherein

said operating comprises generating an instructive signal indicative of an appropriate therapeutic treatment comprising a reduction in the normal dose of at least one medication taken by the patient; and

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

77. The method of claim 76, wherein the transducer is situated within the left atrium.

78. The method of claim 76, wherein the transducer is situated within a pulmonary vein.

79. The method of claim 76, wherein the transducer is situated within the left atrial appendage.

80. The method of claim 76, wherein the transducer is located in the septal wall.

81. The method of claim 76, 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.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment; and

communicating the instructive signal indicative of the appropriate therapeutic treatment to the patient, wherein communicating the signal comprises communicating to the patient at least one predetermined sequence comprising multiple individual signal pulses perceptible by the patient.

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

implanting a pressure transducer 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 an instructive signal indicative of an appropriate therapeutic treatment, wherein operating the signal processing apparatus comprises diagnosing a cause of worsening CHF; and

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