CHRONICALLY IMPLANTED ABDOMINAL PRESSURE SENSOR FOR CONTINUOUS AMBULATORY ASSESSMENT OF RENAL FUNCTIONS

• US 20100152608A1
• Filed: 08/07/2009
• Published: 06/17/2010
• Est. Priority Date: 09/12/2008
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: HATLESTAD, John D., TRAN, Binh C., HEIL, Ronald W. JR., MI, Bin
• Application Number:
  US12/537,403
• Publication Number:
  US 20100152608A1
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• 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 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/416 the spleen
• CPC Class Codes: A61B 5/6846 specially adapted to be brought in contact with an internal body part, i.e. invasive

Abstract

An implantable system for ambulatory monitoring of a high-risk heart failure patient includes a first pressure sensor implantable within an abdomen of the patient for sensing and generating an output representative of a baseline intra-abdominal pressure value of the patient and for chronically sensing and generating an output representative of an intra-abdominal pressure value of the patient at periodic intervals. At least one second implantable sensor is provided for sensing and generating an output representative of a second physiological parameter of the patient. Additionally, the system includes a processor for correlating the output of the first pressure sensor and the second physiologic sensor, and for comparing differences between the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values. The processor can reside in another implantable device or in an external device/system.

Claims

1. A method of monitoring heart functions of a patient, the method comprising:

measuring a first intra-abdominal pressure value of the patient using a first pressure sensor chronically implanted at least partially within an abdomen of the patient;

chronically measuring a plurality of second intra-abdominal pressure values of the patient at periodic intervals when the patient is ambulatory using the first pressure sensor;

remotely transmitting the first and second intra-abdominal pressure values to one or both of an external device and an implant within the patient;

associating the second intra-abdominal pressure values with an output from at least one second implantable physiologic sensor to obtain a plurality of correlated second intra-abdominal pressure values;

comparing the first intra-abdominal pressure value to the associated second intra-abdominal pressure values; and

associating a difference between the first intra-abdominal pressure value and any one or a plurality of the associated second intra-abdominal pressure values with a renal condition linked to heart function.

2. The method of claim 1, further comprising adjusting a therapy based on a difference between the first intra-abdominal pressure value and any one or a plurality of the associated second intra-abdominal pressure values.

3. The method of claim 2, wherein the therapy is a renal therapy.

4. The method of claim 1, further comprising sending a signal to an external device if the difference between the first intra-abdominal pressure and any one or a plurality of the associated second intra-abdominal pressure values is greater than a predetermined value.

5. The method of claim 4, wherein the predetermined value is about 8 mmHg.

6. The method of claim 1, wherein associating the second intra-abdominal pressure values with an output from at least one second implantable physiologic sensor includes associating the second intra-abdominal pressure values with an output from an implanted posture sensor and/or an output from an implanted activity sensor.

7. The method of claim 1, wherein measuring the first intra-abdominal pressure values further includes sensing the intra-abdominal pressure using a second pressure sensor implanted at least partially within the abdomen of the patient, and averaging an output of the first and second pressure sensors to obtain the first intra-abdominal pressure value.

8. The method of claim 7, wherein measuring the plurality of second intra-abdominal pressure values includes sensing intra-abdominal pressure at the periodic intervals using the second pressure sensor, and averaging an output of the first and second pressure sensors generated at the periodic intervals.

9. The method of claim 1, wherein associating the difference between the first intra-abdominal pressure value and any one or a plurality of the second intra-abdominal pressure values includes detecting an onset of renal failure, ascites, and/or early decompensation.

10. The method of claim 9, further comprising alerting a clinician upon detection of the onset of renal failure, ascites, and/or early decompensation.

11. The method of claim 1, wherein remotely transmitting the first and second intra-abdominal pressure values to one or both of an external device and an implant within the patient includes remotely transmitting the values through acoustic, RF, or optical communication.

12. A method of monitoring heart functions of a patient, the method comprising:

measuring a plurality of intra-abdominal pressure values of the patient when the patient is ambulatory using a first implanted pressure sensor; and

associating one or more elevated intra-abdominal pressure values with one or more signs of deteriorating heart condition.

13. The method of claim 12, wherein the signs of deteriorating heart condition is one or more of ascites and compromised renal function.

14. The method of claim 12, further comprising remotely transmitting the intra-abdominal pressure values to one or both of an external device and an implant within the patient.

15. The method of claim 14, wherein remotely transmitting the intra-abdominal pressure values to one or both of an external device and an implant within the patient includes remotely transmitting the values through acoustic, RF, or optical communication.

16. The method of claim 12, wherein measuring a plurality of intra-abdominal pressure values includes measuring a first intra-abdominal pressure value of the patient as a baseline intra-abdominal pressure value and chronically measuring a plurality of second intra-abdominal pressure values of the patient at periodic intervals.

17. The method of claim 16, further comprising associating the first and second intra-abdominal pressure values with an output from at least one second implantable physiologic sensor to obtain a plurality of associated second intra-abdominal pressure values.

18. The method of claim 17, wherein associating one or more elevated intra-abdominal pressure values includes associating a difference between the first intra-abdominal pressure value and any one or a plurality of the associated second intra-abdominal pressure values to a renal condition linked to heart function.

19. The method of claim 12, wherein measuring the plurality of intra-abdominal pressure values further includes measuring the intra-abdominal pressure values using a second pressure sensor implanted at least partially within the abdomen of the patient, and averaging an output of the first and second pressure sensors to obtain the intra-abdominal pressure values.

20. An implantable system for ambulatory monitoring of a high-risk heart failure patient comprising:

a first pressure sensor implantable within an abdomen of the patient for sensing and generating an output representative of a baseline intra-abdominal pressure value of the patient and for chronically sensing and generating an output representative of an intra-abdominal pressure value of the patient at periodic intervals;

at least one second implantable sensor for sensing and generating an output representative of a second physiological parameter of the patient; and

a processor for correlating the output of the first pressure sensor and the output of the second physiologic sensor, and for comparing differences between the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values.

21. The implantable system of claim 20, further comprising an external system for determining a therapy based on the differences between the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values to treat heart failure.

22. The implantable system of claim 20, further comprising an external system for alerting a clinician when the difference between the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values exceeds a predetermined amount.

23. The implantable system of claim 20, wherein the first pressure sensor is configured to remotely transmit the output representative of the intra-abdominal pressure values to one or both of an external device and an implant in the patient.

24. The implantable system of claim 21, wherein the at least one second physiologic sensor is a posture sensor for determining posture of the patient.

25. The implantable system of claim 20, further comprising means for transmitting the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values to the processor.

26. The implantable system of claim 20, further comprising an indicator for alerting the patient when the difference between the baseline intra-abdominal pressure value and subsequent intra-abdominal pressure values is greater than a predetermined amount.

27. The implantable system of claim 20, further comprising an indicator for alerting a third party when the difference between the baseline intra-abdominal pressure. value and subsequent intra-abdominal pressure values is greater than a predetermined amount.

28. The implantable system of claim 20, further comprising a second pressure sensor implantable within the abdomen of the patient for measuring the baseline intra-abdominal pressure of the patient and for chronically measuring the intra-abdominal pressure of the patient, wherein the second pressure sensor is spaced from the first pressure sensor.

29. The implantable system of claim 28, wherein the processor is configured to average the intra-abdominal pressure values sensed by the first pressure sensor and the second pressure sensor.

30. The implantable system of claim 28, wherein the processor correlates the intra-abdominal pressure values sensed by the first pressure sensor and the second pressure sensor to the output of the second physiologic sensor.