Volume monitoring for implantable fluid delivery devices

• US 9,687,603 B2
• Filed: 04/16/2010
• Issued: 06/27/2017
• Est. Priority Date: 04/16/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ali, Irfan Z., Kalpin, Scott L., Miesel, Keith A., Nelson Konen, Cynthia R.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US12/762,064
• Publication Number:
  US 20110257591A1
• Time in Patent Office: 2,629 Days
• Field of Search: 604 67, 604 65, 604505, 702 55, 700281, 340540
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3379 Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

Unexpected changes in the volume of therapeutic fluid in the reservoir of a fluid delivery device are detected based on changes in the pressure of the reservoir measured over a period of time by a pressure sensor. Additionally, an ambulatory reservoir fluid volume gauge is provided to indicate an actual volume of therapeutic fluid in a fluid delivery device reservoir. The actual volume of therapeutic fluid in the reservoir indicated by the ambulatory reservoir fluid volume gauge is determined based on changes in the pressure in the reservoir measured over a period of time by a pressure sensor.

Claims

1. A therapeutic fluid delivery system comprising:

a reservoir configured to house a therapeutic fluid;

a pressure sensor configured to measure a pressure of the reservoir; and

a processor configured to determine at least one of a difference between an actual rate at which the therapeutic fluid is delivered from the reservoir and a rate at which the therapeutic fluid is expected to be delivered from the reservoir or a difference between an actual volume and an expected volume of therapeutic fluid in the reservoir based on changes in the pressure of the reservoir measured by the pressure sensor over time and detect an unexpected change in a volume of the therapeutic fluid in the reservoir when at least one of the difference between the actual rate at which the therapeutic fluid is delivered from the reservoir and the rate at which the therapeutic fluid is expected to be delivered from the reservoir is greater than a first threshold or the difference between the actual volume and the expected volume of therapeutic fluid in the reservoir is greater than a second threshold,

wherein the first and second thresholds decrease as a time period over which the changes in the pressure of the reservoir are measured by the pressure sensor increases.

2. The system of claim 1, wherein the processor is configured to determine the actual rate at which the therapeutic fluid is delivered from the reservoir at least by dividing a change in the pressure of the reservoir measured by the pressure sensor over a time period by a constant representing the sensitivity of the pressure of the reservoir to changes in the volume of therapeutic fluid in the reservoir.

3. The system of claim 2, wherein the processor is configured to perform a linear regression of the change in the pressure measured by the pressure sensor to normalize the change in the pressure of the reservoir measured by the pressure sensor over the time period for temperature changes in the reservoir.

4. The system of claim 3, wherein the linear regression comprises a least squares linear regression.

5. The system of claim 2, further comprising a temperature sensor configured to measure a temperature of the reservoir, wherein the processor is configured to normalize the change in the pressure of the reservoir measured by the pressure sensor over the time period for temperature changes based on changes in the temperature of the reservoir measured by the temperature sensor over the time period.

6. The system of claim 1, wherein the expected rate at which the therapeutic fluid is delivered from the reservoir corresponds to a rate at which the processor is programmed to control a pump to deliver the therapeutic fluid from the reservoir.

7. The system of claim 6, further comprising a memory configured to store the rate at which the processor is programmed to control the pump to deliver the therapeutic fluid from the reservoir.

8. The system of claim 1, wherein the processor is configured to generate an alert when the difference between the actual rate and the expected rate is greater than the first threshold.

9. The system of claim 1, wherein the processor is configured to determine the actual volume of therapeutic fluid in the reservoir at least by:

determining the actual rate at which the therapeutic fluid is delivered from the reservoir based on the changes in the pressure of the reservoir measured by the pressure sensor over time;

multiplying the actual rate by a time period over which the changes in the pressure of the reservoir are measured by the pressure sensor to determine an actual volume of therapeutic fluid delivered from the reservoir over the time period; and

subtracting the actual volume of therapeutic fluid delivered from the reservoir over the time period from a starting volume of therapeutic fluid in the reservoir.

10. The system of claim 9, wherein the processor is configured to determine the actual rate at which the therapeutic fluid is delivered from the reservoir at least by dividing a change in the pressure of the reservoir measured by the pressure sensor over a time period by a constant representing the sensitivity of the pressure of the reservoir to changes in the volume of therapeutic fluid in the reservoir.

11. The system of claim 9, wherein the processor is configured to perform a linear regression of the change in the pressure measured by the pressure sensor to normalize the change in the pressure of the reservoir measured by the pressure sensor over the time period for temperature changes in the reservoir.

12. The system of claim 1, wherein the processor is configured to determine the expected volume of therapeutic fluid in the reservoir at least by subtracting a volume of therapeutic fluid expected to be delivered from the reservoir over a time period over which the changes in the pressure of the reservoir are measured by the pressure sensor from a starting volume of therapeutic fluid in the reservoir.

13. The system of claim 12, wherein the processor is configured to determine the expected volume of therapeutic fluid delivered from the reservoir at least by multiplying a rate at which the therapeutic fluid is expected to be delivered from the reservoir over the time period by the time period.

14. The system of claim 12, wherein the processor is configured to determine the expected volume of therapeutic fluid delivered from the reservoir at least by multiplying a number of strokes of a pump configured to deliver the therapeutic fluid from the reservoir by a volume of fluid pumped per stroke.

15. The system of claim 1, wherein the processor is configured to generate an alert when the difference between the actual volume and the expected volume is greater than the second threshold.

16. The system of claim 1, wherein the processor is configured to generate an alert when the unexpected change in the volume of therapeutic fluid in the reservoir is detected.

17. The system of claim 16, wherein the alert comprises at least one of an audible, visual, or tactile alert.

18. The system of claim 1 further comprising a fluid delivery device comprising the reservoir, and wherein the processor is configured to cause the fluid delivery device to at least one of vibrate or issue an audible sound when the unexpected change in the volume of therapeutic fluid in the reservoir is detected.

19. The system of claim 18, wherein the fluid delivery device comprises the processor.

20. The system of claim 1 further comprising a programmer, wherein the processor is configured to cause the programmer to at least one of vibrate, issue an audible sound, or display a visual message when the unexpected change in the volume of therapeutic fluid in the reservoir is detected.

21. The system of claim 20, wherein the programmer comprises the processor.

22. The system of claim 1 further comprising a memory configured to store one or more pressures of the reservoir measured by the pressure sensor.

23. The system of claim 1, wherein the first threshold comprises a percentage deviation between the actual rate at which the therapeutic fluid is delivered from the reservoir and the rate at which the therapeutic fluid is expected to be delivered from the reservoir.

24. The system of claim 23, wherein the time period over which the changes in the pressure of the reservoir are measured by the pressure sensor is less than or equal to 24 hours and wherein the first threshold comprises a percentage deviation between the actual and expected fluid delivery rates approximately equal to +/−

500% such that the processor detects the unexpected change in the volume of therapeutic fluid in the reservoir when the actual rate at which the therapeutic fluid is delivered from the reservoir deviates from the rate at which the therapeutic fluid is expected to be delivered from the reservoir by greater than or equal to +/−

500%.

25. The system of claim 23, wherein the time period over which the changes in the pressure of the reservoir are measured by the pressure sensor is greater than 24 hours and less than 120 hours and wherein the first threshold comprises a percentage deviation between the actual and expected fluid delivery rates approximately equal to +/−

100% such that the processor detects the unexpected change in the volume of therapeutic fluid in the reservoir when the actual rate at which the therapeutic fluid is delivered from the reservoir deviates from the rate at which the therapeutic fluid is expected to be delivered from the reservoir by greater than or equal to +/−

100%.

26. The system of claim 23, wherein the time period over which the changes in the pressure of the reservoir are measured by the pressure sensor is greater than 120 hours and less than 168 hours and wherein the first threshold comprises a percentage deviation between the actual and expected fluid delivery rates approximately equal to +/−

25% such that the processor detects the unexpected change in the volume of therapeutic fluid in the reservoir when the actual rate at which the therapeutic fluid is delivered from the reservoir deviates from the rate at which the therapeutic fluid is expected to be delivered from the reservoir by greater than or equal to +/−

25%.

27. The system of claim 23, wherein the time period over which the changes in the pressure of the reservoir are measured by the pressure sensor is greater than 168 hours and wherein the first threshold comprises a percentage deviation between the actual and expected fluid delivery rates approximately equal to +/−

12% such that the processor detects the unexpected change in the volume of therapeutic fluid in the reservoir when the actual rate at which the therapeutic fluid is delivered from the reservoir deviates from the rate at which the therapeutic fluid is expected to be delivered from the reservoir by greater than or equal to +/−

12%.

28. A method comprising:

measuring a pressure of a reservoir of a fluid delivery device with a pressure sensor;

determining at least one of a difference between an actual rate at which the therapeutic fluid is delivered from the reservoir and a rate at which the therapeutic fluid is expected to be delivered from the reservoir or a difference between an actual volume and an expected volume of therapeutic fluid in the reservoir based on changes in the pressure of the reservoir measured by the pressure sensor over time; and

detecting an unexpected change in a volume of therapeutic fluid in the reservoir when at least one of the difference between the actual rate at which the therapeutic fluid is delivered from the reservoir and the rate at which the therapeutic fluid is expected to be delivered from the reservoir is greater than a first threshold or the difference between the actual volume and the expected volume of therapeutic fluid in the reservoir is greater than a second threshold,

wherein the first and second thresholds decrease as a time period over which the changes in the pressure of the reservoir are measured by the pressure sensor increases.

29. The method of claim 28, wherein determining the actual rate at which the therapeutic fluid is delivered from the reservoir comprises dividing a change in the pressure of the reservoir measured by the pressure sensor over a time period by a constant representing the sensitivity of the pressure of the reservoir to changes in the volume of therapeutic fluid in the reservoir.

30. The method of claim 29 further comprising performing a linear regression of the change in the pressure measured by the pressure sensor to normalize the change in the pressure of the reservoir measured by the pressure sensor over the time period for temperature changes in the reservoir.

31. The method of claim 30, wherein the linear regression comprises a least squares linear regression.

32. The method of claim 29 further comprising normalizing the change in the pressure of the reservoir measured by the pressure sensor over the time period for temperature changes in the reservoir based on changes in the temperature of the reservoir measured by a temperature sensor over the time period.

33. The method of claim 28 further comprising generating an alert when the difference between the actual rate and the expected rate is greater than the first threshold.

34. The method of claim 33, wherein the alert comprises at least one of an audible, visual, or tactile alert.

35. The method of claim 28 further comprising causing the fluid delivery device to at least one of vibrate or issue an audible sound when the unexpected change in the volume of therapeutic fluid in the reservoir is detected.

36. A non-transitory computer-readable storage medium comprising instructions for causing a programmable processor to:

cause a pressure sensor to measure a pressure of a reservoir of a fluid delivery device with a pressure sensor;

determine at least one of a difference between an actual rate at which the therapeutic fluid is delivered from the reservoir and a rate at which the therapeutic fluid is expected to be delivered from the reservoir or a difference between an actual volume and an expected volume of therapeutic fluid in the reservoir based on changes in the pressure of the reservoir measured by the pressure sensor over time; and

detect an unexpected change in a volume of therapeutic fluid in the reservoir when at least one of the difference between the actual rate at which the therapeutic fluid is delivered from the reservoir and the rate at which the therapeutic fluid is expected to be delivered from the reservoir is greater than a first threshold or the difference between the actual volume and the expected volume of therapeutic fluid in the reservoir is greater than a second threshold,

wherein the first and second thresholds decrease as a time period over which the changes in the pressure of the reservoir are measured by the pressure sensor increases.

37. A fluid delivery system comprising:

means for measuring a pressure of a reservoir of a fluid delivery device;

means for determining at least one of a difference between an actual rate at which the therapeutic fluid is delivered from the reservoir and a rate at which the therapeutic fluid is expected to be delivered from the reservoir or a difference between an actual volume and an expected volume of therapeutic fluid in the reservoir based on changes in the pressure of the reservoir measured over time by the means for measuring the pressure of the reservoir; and

means for detecting an unexpected change in a volume of therapeutic fluid in the reservoir when at least one of the difference between the actual rate at which the therapeutic fluid is delivered from the reservoir and the rate at which the therapeutic fluid is expected to be delivered from the reservoir is greater than a first threshold or the difference between the actual volume and the expected volume of therapeutic fluid in the reservoir is greater than a second threshold,

wherein the first and second thresholds decrease as a time period over which the changes in the pressure of the reservoir are measured by the means for measuring the pressure of the reservoir increases.

38. A therapeutic fluid delivery system comprising:

an outer housing;

a reservoir within the outer housing and configured to house a therapeutic fluid;

a pressure sensor configured to measure a first pressure of the therapeutic fluid in the reservoir at a first time and a second pressure of the therapeutic fluid in the reservoir at a second time;

an ambulatory reservoir fluid volume gauge; and

a processor configured to receive the first pressure of the therapeutic fluid in the reservoir and the second pressure of the therapeutic fluid in the reservoir, determine a change in pressure of the therapeutic fluid in the reservoir over time between the first pressure and the second pressure measured by the pressure sensor, determine an actual volume of the therapeutic fluid in the reservoir based on the change in pressure of the therapeutic fluid in the reservoir determined by the processor, and control the ambulatory fluid volume gauge to indicate the actual volume of the therapeutic fluid in the reservoir,

wherein the ambulatory reservoir fluid volume gauge comprises a visual representation of the actual volume of the therapeutic fluid in the reservoir.

39. The system of claim 38, wherein the ambulatory reservoir fluid volume gauge comprises a display of the visual representation of the actual volume of the therapeutic fluid in the reservoir.

40. The system of claim 39, wherein the ambulatory reservoir fluid volume gauge comprises at least one of a text or graphical representation of the actual volume of the therapeutic fluid in the reservoir.

41. The system of claim 39 further comprising a programmer, wherein the programmer comprises the ambulatory reservoir fluid volume gauge.

42. The system of claim 38, wherein the processor is configured to determine the actual volume of therapeutic fluid in the reservoir at least by:

determining an actual rate at which the therapeutic fluid is delivered from the reservoir based on the change in pressure of the therapeutic fluid in the reservoir measured by the pressure sensor; and

determining the actual volume of the therapeutic fluid in the reservoir based on the actual rate at which the therapeutic fluid is delivered from the reservoir.

43. The system of claim 42, wherein the processor is configured to determine the actual rate at which the therapeutic fluid is delivered from the reservoir at least by dividing the change in pressure of the therapeutic fluid in the reservoir measured by the pressure sensor over a time period by a constant representing the sensitivity of the pressure of the reservoir to changes in the volume of the therapeutic fluid in the reservoir.

44. The system of claim 43, wherein the processor is configured to normalize the change in pressure of the therapeutic fluid in the reservoir measured by the pressure sensor over the time period for temperature changes at least by performing a linear regression of the change in the pressure measured by the pressure sensor.

45. The system of claim 44, wherein the linear regression comprises a least squares linear regression.

46. The system of claim 43 further comprising a temperature sensor configured to measure a temperature of the reservoir, wherein the processor is configured to normalize the change in pressure of the therapeutic fluid in the reservoir measured by the pressure sensor over the time period for temperature changes based on changes in the temperature of the reservoir measured by the temperature sensor over the time period.

47. The system of claim 38, wherein the processor is configured to determine the actual volume of the therapeutic fluid in the reservoir at least by integrating the actual rate at which the therapeutic fluid is delivered from the reservoir over a time period over which the change in pressure of the therapeutic fluid in the reservoir are measured by the pressure sensor.

48. A method comprising:

measuring a first pressure of a therapeutic fluid in a reservoir of a fluid delivery device at a first time and a second pressure of the therapeutic fluid in the reservoir at a second time with a pressure sensor;

receiving the first pressure of the therapeutic fluid in the reservoir and the second pressure of the therapeutic fluid in the reservoir;

determining a change in pressure of the therapeutic fluid in the reservoir over time between the first pressure and the second pressure measured by the pressure sensor;

determining an actual volume of therapeutic fluid in the reservoir based on the change in pressure of the therapeutic fluid in the reservoir determined by the processor; and

controlling an ambulatory fluid volume gauge to indicate the actual volume of the therapeutic fluid in the reservoir,

wherein the ambulatory reservoir fluid volume gauge comprises a visual representation of the actual volume of the therapeutic fluid in the reservoir.

49. The method of claim 48, wherein the ambulatory reservoir fluid volume gauge comprises a display of the visual representation of the actual volume the of therapeutic fluid in the reservoir.

50. The method of claim 49, wherein the ambulatory reservoir fluid volume gauge comprises at least one of a text or graphical representation of the actual volume of the therapeutic fluid in the reservoir.

51. The method of claim 48, wherein determining the actual volume of the therapeutic fluid in the reservoir comprises:

determining an actual rate at which the therapeutic fluid is delivered from the reservoir based on the change in pressure of the therapeutic fluid in the reservoir measured by the pressure sensor; and

determining the actual volume of the therapeutic fluid in the reservoir based on the actual rate at which the therapeutic fluid is delivered from the reservoir.

52. The method of claim 51, wherein determining the actual rate at which the therapeutic fluid is delivered from the reservoir comprises dividing the change in pressure of the reservoir measured by the pressure sensor over a time period by a constant representing the sensitivity of the pressure of the therapeutic fluid in the reservoir to changes in the volume of the therapeutic fluid in the reservoir.

53. The method of claim 51, further comprising normalizing the change in pressure of the therapeutic fluid in the reservoir measured by the pressure sensor over the time period for temperature changes at least by performing a linear regression of the change in the pressure measured by the pressure sensor.

54. The method of claim 53, wherein the linear regression comprises a least squares linear regression.

55. The method of claim 48, wherein determining the actual volume of the therapeutic fluid in the reservoir comprises integrating the actual rate at which the therapeutic fluid is delivered from the reservoir over a time period over which the change in pressure of the therapeutic fluid in the reservoir are measured by the pressure sensor.

56. A fluid delivery system comprising:

means for measuring a first pressure of a therapeutic fluid in a reservoir of a fluid delivery device at a first time and a second pressure of the therapeutic fluid in the reservoir at a second time;

means for receiving the first pressure of the therapeutic fluid in the reservoir and the second pressure of the therapeutic fluid in the reservoir;

means for determining a change in pressure of the therapeutic fluid in the reservoir over time between the first pressure and the second pressure measured by the pressure sensor;

means for determining an actual volume of therapeutic fluid in the reservoir based on the change in pressure of the therapeutic fluid in the reservoir determined by the means for determining the change in pressure of the therapeutic fluid in the reservoir over time; and

means for controlling an ambulatory fluid volume gauge to indicate the actual volume of the therapeutic fluid in the reservoir,

wherein the ambulatory reservoir fluid volume gauge comprises a visual representation of the actual volume of the therapeutic fluid in the reservoir.

57. A non-transitory computer-readable storage medium comprising instructions for causing a programmable processor to:

measure a first pressure of a therapeutic fluid in a reservoir of a fluid delivery device at a first time and a second pressure of the therapeutic fluid in the reservoir at a second time with a pressure sensor;

receive the first pressure of the therapeutic fluid in the reservoir and the second pressure of the therapeutic fluid in the reservoir;

determine a change in pressure of the therapeutic fluid in the reservoir over time between the first pressure and the second pressure measured by the pressure sensor;

determine an actual volume of therapeutic fluid in the reservoir based on the change in pressure of the therapeutic fluid in the reservoir determined by the programmable processor; and

control an ambulatory fluid volume gauge to indicate the actual volume of the therapeutic fluid in the reservoir,

wherein the ambulatory reservoir fluid volume gauge comprises a visual representation of the actual volume of the therapeutic fluid in the reservoir.

58. A method comprising:

measuring a pressure of a therapeutic fluid in a reservoir of a fluid delivery device with a pressure sensor;

determining an actual rate at which the therapeutic fluid is delivered from the reservoir based on changes in the pressure of the therapeutic fluid in the reservoir measured by the pressure sensor;

integrating the actual rate at which the therapeutic fluid is delivered from the reservoir over a period of time over which changes in the pressure of the therapeutic fluid in the reservoir are measured by the pressure sensor to determine an actual volume of therapeutic fluid in the reservoir; and

controlling an ambulatory fluid volume gauge to indicate the actual volume of the therapeutic fluid in the reservoir,

wherein the ambulatory reservoir fluid volume gauge comprises a visual representation of the actual volume of the therapeutic fluid in the reservoir.

59. The method of claim 58, wherein determining the actual rate at which the therapeutic fluid is delivered from the reservoir comprises dividing a change in the pressure of the therapeutic fluid in the reservoir measured by the pressure sensor over a time period by a constant representing the sensitivity of the pressure of the reservoir to changes in the volume of the therapeutic fluid in the reservoir.

60. The method of claim 59 further comprising normalizing the change in the pressure of the therapeutic fluid in the reservoir measured by the pressure sensor over the time period for temperature changes at least by performing a linear regression of the change in the pressure measured by the pressure sensor.