Detection of hypovolemia using implantable medical device

• US 7,798,973 B2
• Filed: 10/13/2005
• Issued: 09/21/2010
• Est. Priority Date: 10/13/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E.
• Primary Examiner(s): Nasser; Robert L
• Assistant Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US11/249,611
• Publication Number:
  US 20070088220A1
• Time in Patent Office: 1,804 Days
• Field of Search: 600483-486, 607 9- 17
• US Class Current: 600/485
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

An implantable medical device receives a physiological signal indicative of circulatory blood volume and detects hypovolemia from that physiological signal. In one embodiment, an implantable pulmonary artery pressure (PAP) senses a PAP signal, and the implantable medical device detects hypovolemia from the PAP signal.

Claims

1. A system for use in a body having a pulmonary artery, comprising:

an implantable pulmonary artery pressure (PAP) sensor configured to be mounted on an interior wall of the pulmonary artery and sense a PAP signal indicative of a volume of circulating blood; and

an implantable medical device communicatively coupled to the implantable PAP sensor via a wireless telemetry link, the implantable medical device comprising;

a signal processor adapted to process the PAP signal; and

a hypovolemia detector adapted to produce a diastolic PAP (DPAP) using the processed PAP signal, detect hypovolemia using at least the DPAP, and produce a hypovolemia detection signal indicative of the detection of hypovolemia.

2. The system of claim 1, comprising a stent-like anchoring structure coupled to the implantable PAP sensor and configured to anchor the implantable PAP sensor to the pulmonary artery.

3. The system of claim 2, wherein the stent-like structure comprises a mesh structure, and the implantable PAP sensor is embedded in the mesh structure.

4. The system of claim 3, wherein the implantable medical device is communicatively coupled to the implantable PAP sensor via an ultrasonic telemetry link.

5. The system of claim 1, wherein the signal processor comprises an atmospheric pressure adjustment module adapted to adjust the PAP signal using an atmospheric pressure, and further comprising an external pressure sensor communicatively coupled to the implantable medical device, the external pressure sensor comprising a barometer to sense the atmospheric pressure.

6. The system of claim 1, wherein the signal processor comprises a posture adjustment module adapted to adjust the PAP signal using a posture signal, and further comprising a posture sensor adapted to sense the posture signal.

7. The system of claim 1, wherein the PAP signal processor comprises a respiration adjustment module adapted to adjust the PAP signal using a respiratory signal, and further comprising a respiratory sensor adapted to sense the respiratory signal.

8. The system of claim 1, wherein the hypovolemia detector comprises:

a PAP attribute producer adapted to produce a PAP attribute using the processed PAP signal; and

a detection comparator adapted to detect hypovolemia by comparing the PAP attribute to a hypovolemia-detection threshold and to produce the hypovolemia detection signal when the hypovolemia is detected.

9. The system of claim 8, wherein the PAP attribute producer is adapted to produce the DPAP and one or more of a systolic PAP (SPAP), a PAP pulse pressure, a timing of a dicrotic notch in the PAP signal relative to another PAP feature such as a peak (SPAP), a maximum rate of change in PAP (maximum dPAP/dt), and a minimum rate of change in PAP (minimum dPAP/dt), a (SPAP) time interval, and a DPAP time interval.

10. The system of claim 8, wherein the PAP attribute is a mean PAP (MPAP), and the PAP attribute producer comprises:

a DPAP producer adapted to produce the DPAP using the processed PAP signal;

a systolic PAP (SPAP) producer adapted to produce an SPAP using the processed PAP signal; and

an MPAP calculator adapted to calculate the MPAP using the DPAP and the SPAP.

11. The system of claim 8, wherein the hypovolemia detector further comprises a baseline generator adapted to produce a baseline of the PAP attribute, and wherein the detection comparator is adapted to produce the hypovolemia detection signal by comparing the PAP attribute to a predetermined percentage of the baseline of the PAP attribute.

12. The system of claim 11, wherein the baseline generator comprises:

a short-term PAP attribute producer adapted to produce short-term value of the PAP attribute on a periodic basis, the short-term PAP attribute producer including;

a PAP sampler adapted to produce samples of the PAP signal; and

a short-term PAP attribute calculator adapted to calculate each of the short-term values of the PAP attribute by averaging a plurality of the samples of the PAP signal; and

a moving averager adapted to produce the baseline of the PAP attribute by calculating a moving average of a plurality of the short-term values of the PAP attribute on the periodic basis.

13. The system of claim 8, wherein the hypovolemia detector further comprises a prediction comparator adapted to produce a hypovolemia prediction signal indicative of a prediction of hypovolemia by comparing the PAP attribute to a hypovolemia-prediction threshold.

14. The system of claim 1, wherein the implantable medical device further comprises a hypovolemia detection enhancement module to enhance the detection of hypovolemia using one or more enhancement signals including one or more of a signal indicative of loss of body weight, a signal indicative of increased heart rate, a signal indicative of increased respiratory rate, a signal indicative of postural hypotension, a signal indicative of decreased pulse pressure, a signal indicative of delayed dicrotic notch, a signal indicative of increased hemoglobin, and a signal indicative of increased hematocrit.

15. The system of claim 14, further comprising a warning message generator adapted to produce a warning message based on at least one of the hypovolemia detection signal and the one or more enhancement signals, the warning message including at least one of an alarm signal indicative of an occurrence of the hypovolemia and a caution signal indicative of an elevated risk of hypovolemia.

16. The system of claim 1, wherein the implantable medical device further comprises:

a therapy delivery device adapted to deliver one or more therapies; and

a therapy controller adapted to control the delivery of the one or more therapies using at least the hypovolemia detection signal.

17. The system of claim 1, wherein the implantable medical device further comprises an edema detector adapted to produce an edema detection signal indicative of a detection of edema.

18. The system of claim 17, wherein the implantable medical device further comprises:

a therapy delivery device adapted to deliver one or more therapies; and

a therapy controller adapted to control the delivery of the one or more therapies using at least the hypovolemia detection signal and the edema detection signal.

19. The system of claim 18, wherein the therapy delivery device comprises a drug delivery device adapted to deliver one or more diuretic agents.

20. A method for operating an implantable medical device, the method comprising:

receiving a pulmonary artery pressure (PAP) signal from an implantable PAP sensor via a wireless telemetry link, the implantable PAP sensor mounted on an interior wall of a pulmonary artery to sense the PAP signal;

producing a diastolic PAP (DPAP) using the PAP signal; and

detecting hypovolemia using at least the DPAP using the implantable medical device.

21. The method of claim 20, wherein receiving the PAP signal comprises receiving the PAP signal from the implantable PAP sensor anchored to the pulmonary artery using a stent-like anchoring structure.

22. The method of claim 20, wherein detecting the hypovolemia comprises:

producing a PAP attribute using the PAP signal;

detecting a hypovolemia by comparing the PAP attribute to a hypovolemia-detection threshold; and

producing a hypovolemia detection signal when the hypovolemia is detected.

23. The method of claim 22, further comprising:

sensing an atmospheric pressure; and

adjusting the PAP signal using the atmospheric pressure prior to producing the PAP attribute.

24. The method of claim 22, further comprising:

sensing a posture signal; and

adjusting the PAP signal using the posture signal prior to producing the PAP attribute.

25. The method of claim 22, further comprising:

sensing a respiratory signal indicative of respiratory cycles; and

adjusting the PAP signal for effects related to respiratory cycles.

26. The method of claim 22, wherein the PAP attribute is a mean PAP (MPAP), and producing the PAP attribute comprises:

detecting a systolic PAP (SPAP) from the PAP signal; and

calculating the MPAP using the DPAP and the SPAP.

27. The method of claim 26, wherein calculating the MPAP comprises using an equation:

MPAP=(2·

DPAP+SPAP)/3.

28. The method of claim 27, wherein the hypovolemia-detection threshold is in a range of approximately 5 to 10 mmHg.

29. The method of claim 22, further comprising producing a baseline of the PAP attribute, and wherein the hypovolemia-detection threshold is a percentage of the baseline of the PAP attribute, the percentage being in a range of approximate 60% to 80%.

30. The method of claim 29, further comprising:

producing a plurality of samples of the PAP signal on a periodic basis using a predetermined period;

calculating a short-term value of the PAP attribute by averaging the samples of the plurality of samples of the PAP signal; and

producing the baseline of the PAP attribute by calculating a moving average of a plurality of the short-term values of the PAP attribute on the periodic basis.

31. The method of claim 30, wherein the predetermined period is in a range of approximately 2 to 12 hours, the plurality of samples of the PAP signal includes approximately 5 to 30 samples, and the plurality of short-term MPAPs are produced over a duration of approximately 5 to 45 days.

32. The method of claim 22, comprising:

comparing the PAP attribute to a hypovolemia-prediction threshold; and

producing a hypovolemia prediction signal indicative of a prediction of hypovolemia based on an outcome of the comparison.

33. The method of claim 22, further comprising enhancing the detection of the hypovolemia using one or more enhancement signals including one or more of a signal indicative of loss of body weight, a signal indicative of increased heart rate, a signal indicative of increased respiratory rate, a signal indicative of postural hypotension, a signal indicative of decreased pulse pressure, a signal indicative of delayed dicrotic notch, a signal indicative of increased hemoglobin, and a signal indicative of increased hematocrit.

34. The method of claim 33, comprising producing at least one of an alarm signal and a caution signal based on at least one of the hypovolemia detection signal and the one or more enhancement signals, the alarming signal indicative of an occurrence of the hypovolemia, the caution signal indicative of an elevated risk of hypovolemia.

35. The method of claim 22, further comprising:

receiving a further physiological signal indicative of a fluid retention;

detecting an edema from the further physiological signal using the implantable medical device; and

producing an edema detection signal when the edema is detected.

36. The method of claim 35, further comprising:

delivering one or more therapies; and

controlling the delivery of the one or more therapies using the hypovolemia detection signal and the edema detection signal.

37. The method of claim 36, wherein delivering the one or more therapies comprises delivering one or more diuretic agents.