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1. (WO2001051123) PERMANENTLY IMPLANTABLE SYSTEM AND METHOD FOR DETECTING, DIAGNOSING AND TREATING CONGESTIVE HEART FAILURE
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CLAIMS
What is claimed is:
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; and
a patient signaling device operable to communicate the signal indicative of the appropriate therapeutic treatment to the patient.

2. The apparatus of claim 1, further comprising an implantable flexible lead providing a signal connection between the pressure transducer and the signal processing apparatus.

3. The apparatus of claim 1, wherein the signal processing apparatus is at least partially contained within a housing, the housing configured for permanent implantation within the patient's body.

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

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

6. The apparatus of claim 5, wherein the apparatus on the lead 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.

7. The apparatus of claim 5, wherein the apparatus on the lead configured to anchor the pressure transducer to the patient's atrial septum comprises at least one anchor deployable by spring force upon the withdrawal of a removable sheath to expose the anchor.

8. The apparatus of claim 2, wherein the pressure transducer is located on the 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.

9. The apparatus of claim 2, wherein the lead comprises a first lead component carrying apparatus configured to anchor the first lead component to the patient's atrial septum and a second lead component carrying the pressure transducer, wherein the second lead component is implantable into the patient and fixable to the first lead component after the first lead component is implanted within the patient.

10. 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.

11. The apparatus of claim 10, wherein the second sensor is a second pressure transducer.

12. The apparatus of claim 10, wherein the second sensor is an ECG electrode.

13. The apparatus of claim 10, wherein the second sensor is configured for implantation in the patient's right atrium.

14. The apparatus of claim 10, wherein the second sensor is configured for implantation in a location inside the patient's body outside the atria.

15. 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.

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

17. 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.

18. The apparatus of claim 16, further comprising apparatus configured to retrieve the data reflective of pressures within the left atrium from the digital memory.

19. The apparatus of claim 18, wherein the data retrieval apparatus includes a transceiver operable to transmit the data through the patient's skin.

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

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

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

23. 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.

24. 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.

25. The apparatus of claim 1, 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.

26. The apparatus of claim 25, 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.

27. 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.

28. 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.

29. A method for treating congestive heart failure in a medical patient, the method comprising:
implanting a pressure transducer substantially permanently within the left atrium of the patient's heart;
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; and
communicating the signal indicative of the appropriate therapeutic treatment to the patient.

30. The method of claim 29, and further comprising implanting at least a portion of the signal processing apparatus substantially permanently within the patient's body.

31. The method of claim 29, wherein implanting a pressure transducer within the left atrium of the patient's heart comprises: approaching the left atrium through the right atrium;
penetrating the patient's atrial septum; and
positioning the pressure transducer in side the patient's left atrium.

32. The method of claim 31 , and further comprising approaching the right atrium through the superior vena cava.

33. The method of claim 31 , and further comprising approaching the right atrium through the inferior vena cava.

34. The method of claim 29, and further comprising anchoring the pressure transducer to the patient's atrial septum.

35. The method of claim 34, wherein anchoring the pressure transducer to the patient's atrial septum comprises advancing a helical screw into the patient's atrial septum.

36. The method of claim 34, wherein anchoring the pressure transducer to the patient's atrial septum comprises withdrawing a removable sheath to deploy at least one anchor by spring force to bear against the patient's atrial septum.

37. The method of claim 29, and further comprising implanting the signal processing apparatus within the patient's body.

38. The method of claim 34, 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.

39. The method of claim 29, wherein implanting the pressure transducer substantially permanently within the left atrium of the patient's heart includes 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.

40. The method of claim 29, wherein implanting the pressure transducer substantially permanently within the left atrium of the patient's heart 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 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.

41. The method of claim 29, wherein communicating the signal indicative of the appropriate therapeutic treatment includes operating a mechanical vibrator to produce a vibration perceptible by the patient.

42. The method of claim 29, wherein communicating the signal indicative of the appropriate therapeutic treatment includes generating an electrical shock perceptible by the patient.

43. The method of claim 29, wherein communicating the signal indicative of the appropriate therapeutic treatment includes operating a transmitter to send information to a remote receiver.

44. The method of claim 29, 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.

45. The method of claim 29, 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.

46. The method of claim 29, wherein operating the signal processing apparatus to generate a signal indicative of an appropriate therapeutic treatment includes generating one of at least two distinct signals, each said signal indicative of a different therapeutic treatment.

47. The method of claim 46, 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.

48. The method of claim 29, 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.

49. The method of claim 29, 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.

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