Physiological Parameter Analysis for an Implantable Restriction Device and a Data Logger

• US 20090222065A1
• Filed: 02/28/2008
• Published: 09/03/2009
• Est. Priority Date: 04/06/2006
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Brockmeier, Peter, Berger, Matthew, Gayoso, Gaspar M., Krumanaker, David T., Ortiz, Mark S., Dlugos, Daniel F. JR., Plescia, David N., Marcotte, Amy L., Yates, David C., Byrum, Randal T., Doll, Kevin R., Jensen, Dustin R.
• Granted Patent: US 8,152,710 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0257 using atmospheric pressure
• CPC Class Codes: A61B 5/0008 Temperature signals
• 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 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/4205 Evaluating swallowing
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61F 5/0059 with wireless means

Abstract

An implantable restriction device can be configured to provide a restriction in a patient, for example as a function of the pressure of fluid. The implantable restriction device can include one or more sensors configured to sense a variety of parameters, such as pressure of the fluid within the implantable restriction device, pulse width, pulse amplitude, pulse count, pulse duration, or frequency, electrical characteristics, or other parameters. Data obtained by the one or more sensors (for example, the data representing pressure, pulse characteristics, and so on) may be communicated to a device located external to the patient, such as a data logger, using telemetry coils or other communicators. The data logger may store the data, and may communicate the data to a remote location via a network such as the Internet. A docking station may be provided to couple the data logger to a network and/or to recharge a cell in the data logger. The logged data may be analyzed and/or displayed using a variety of techniques to assess and/or track the condition of the restriction device or of the patient, to monitor patient physiology, or for other purposes.

Claims

1. A method of obtaining information about a physiological parameter, comprising:

collecting data from an implantable restriction device over a time period, the collected data containing information about values of a parameter sensed within a body during the time period; and

in a data processing device, analyzing the collected data to determine information about a physiological parameter for at least a portion of the time period.

2. The method of claim 1, wherein the sensed parameter from the body is pressure sensed by the implantable restriction device.

3. The method of claim 1, wherein the physiological parameter is at least one of:

heart rate, breathing rate, peristaltic event occurrence, peristaltic event rate, baseline parameter value.

4. The method of claim 1, wherein the determined information about the physiological parameter is at least one of frequency, value, amplitude, change in value over at least a portion of the time period, and average value over the time period.

5. The method of claim 1, further comprising using the collected data to determine information about a second physiological parameter for at least a portion of the time period.

6. The method of claim 2, further comprising:

determining the frequency content of variations in the values of the sensed parameter during the time period and identifying one or more frequencies in the frequency content as a frequency of the physiological parameter.

7. The method of claim 6, wherein identifying one or more frequencies comprises comparing one or more frequencies to one or more predetermined frequencies that are designated as frequencies associated with the physiological parameter.

8. The method of claim 2, wherein the physiological parameter is a rate of a physiological event, and using the collected data comprises:

determining the frequency content of variations in the values of pressure over at least a portion of the time period;

selecting one or more frequencies existing in the frequency content that fall within a predetermined range of frequencies designated as possible rates of the physiological event; and

identifying a rate for the physiological event based on the one or more selected frequencies.

9. The method of claim 8, wherein identifying comprises at least one of:

(i) averaging the one or more selected frequencies; and

(ii) designating one of the one more frequencies as the rate.

10. The method of claim 8, wherein determining the frequency content comprises applying a Fourier transform to at least a portion of the collected data.

11. The method of claim 8, wherein the physiological event is heartbeat and the rate represents heart rate.

12. The method of claim 8, wherein the physiological event is breath and the rate represents breathing rate.

13. The method of claim 8, further comprising generating an alarm or report if the rate passes a threshold rate.

14. The method of claim 2, wherein the physiological parameter is a rate of a physiological event, and using the collected data comprises:

calculating a frequency exhibited in the variations in the value of pressure over at least a portion of the time period; and

comparing the frequency to a predetermined range of frequencies designated as possible rates of the physiological event to determine if the frequency falls within the range.

15. The method of claim 14, wherein calculating the frequency comprises:

recording at least two times at which values of pressure are at a local maximum or minimum; and

calculating the frequency based on the difference between the at least two times.

16. The method of claim 14, further comprising:

determining an amplitude of the variations in the values of pressure at the calculated frequency; and

comparing the amplitude to a predetermined range of amplitudes designated as possible physiological event amplitudes to determine if the amplitude falls within the range.

17. The method of claim 14, wherein the physiological event is heartbeat and the rate represents heart rate.

18. The method of claim 14, wherein the physiological event is breath and the rate represents breathing rate.

19. The method of claim 14, further comprising generating an alarm or report if the rate passes a threshold rate.

20. The method of claim 2, wherein using the collected data comprises:

calculating the difference between (i) a value of pressure at a time within the time period, and (ii) an average value of pressure at the time, wherein the difference represents a value corresponding to the physiological parameter.

21. The method of claim 20, wherein the physiological parameter is at least one of:

heart rate and breathing rate.

22. The method of claim 20, wherein the average value is calculated based on a group of values in an averaging window that surrounds the value at the time.

23. A method of analyzing data from an implantable restriction device to determine a baseline value for a physiological parameter, comprising:

collecting data from an implantable restriction device over a time period, the collected data containing information about values of a parameter sensed within a body over the time period;

in a data processing device;

defining a range of values to represent a tolerance range; and

comparing one or more values of the sensed parameter during the time period to the tolerance range to determine if all of the one or more values fell within the tolerance range, and if so, identifying a baseline as having been established.

24. The method of claim 23, further comprising calculating a running average based on the values of the sensed parameter during an averaging window within the time period;

and identifying the running average as the baseline value.

25. The method of claim 23, further comprising generating an alarm or report upon the occurrence of an event that is at least one of:

(i) identification of the baseline value;

(ii) failure to identify the baseline value within a threshold time; and

(iii) identification of the baseline value and the baseline value passes a threshold value.

26. The method of claim 23, wherein the range of values are defined with respect to the running average.

27. The method of claim 23, wherein the range of values are defined by an upper limit that exceeds the running average and a lower limit that is less than the running average.

28. The method of claim 23, wherein the sensed parameter is pressure sensed by the implantable restriction device.

29. The method of claim 23, wherein the implantable restriction device is fluid-fillable, and further comprising correlating the determined baseline value to a condition of the implantable restriction device, the condition being one of optimally-filled, over-filled, or under-filled.

30. The method of claim 23, further comprising adding or removing fluid from the implantable restriction device.

31. A method of analyzing data from an implantable restriction device to determine information about a baseline of a physiological parameter, comprising:

collecting data from an implantable restriction device over a time period, the collected data containing information about values of a parameter sensed within a body during the time period; and

calculating, based at least in part on one or more values of the sensed parameter during the time period, a predicted amount of time until the rate of change of values of the physiological parameter will be about zero, the value of the physiological parameter when the rate of change is about zero representing a baseline value.

32. The method of claim 31, wherein the sensed parameter is pressure sensed by the implantable restriction device.

33. The method of claim 31, wherein calculating the predicted amount of time comprises:

calculating a rate of change of the values of the sensed parameter for a window within the time period;

calculating a rate at which the rate of change is changing; and

calculating the predicted amount of time until the values of the sensed parameter will have a rate of change that is about zero based at least in part on the rate of change and the rate at which the rate of change is changing.

34. The method of claim 33, wherein calculating the predicted amount of time further comprises:

dividing the rate of change by the rate at which the rate of change is changing and multiplying by a period of the window to obtain the predicted amount of time until the values of the sensed parameter will have a rate of change that is about zero.

35. The method of claim 33, further comprising:

calculating, based at least in part on the values of the sensed parameter during the time period and the predicted amount of time, a predicted baseline value of the sensed parameter when the rate of change is about zero.

36. The method of claim 35, wherein calculating the predicted baseline value comprises:

extrapolating from one or more values within the window to the predicted baseline value of the sensed parameter, at least by multiplying the rate of change of the values of the sensed parameter for the window within the time period and the predicted amount of time until the values of the sensed parameter will have a rate of change that is about zero.

37. The method of claim 31, further comprising generating an alarm or report if the rate of change passes a threshold value.

38. The method of claim 31, wherein the implantable restriction device is fluid-fillable, and further comprising correlating the rate of change to a condition of the implantable restriction device, the condition being one of:

optimally-filled, over-filled, or under-filled.