Monitoring conditions of implantable medical fluid delivery device

• US 8,998,841 B2
• Filed: 12/07/2010
• Issued: 04/07/2015
• Est. Priority Date: 12/11/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shen, Jiaying, Akpan, Emem D.
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US12/961,874
• Publication Number:
  US 20110144540A1
• Time in Patent Office: 1,582 Days
• Field of Search: 604 65- 67, 604/246, 604/500, 604/506, 604/512, 604/513
• US Class Current: 604/67
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A programmer device includes an interface that communicates with an implantable fluid delivery device and a user interface that allows a user to troubleshoot a catheter connected to the fluid delivery device by measuring a pressure associated with the catheter. A processor may compare the measured pressure waveform to a previously-acquired waveform or the user interface may display the measured pressure waveform for the user to compare the displayed pressure waveform to a previously-acquired baseline waveform. The comparison between the two waveforms may be based on the pressure decay time. A historical log of measured pressure decays associated with the catheter may be maintained by the programmer device or the implantable fluid delivery device and displayed for the user to determine whether the performance of the catheter is deteriorating.

Claims

1. A method of troubleshooting a catheter associated with an implantable medical fluid delivery device, the method comprising:

delivering a fluid from the implantable medical fluid delivery device through the catheter to a patient;

measuring a pressure associated with the catheter during the delivery of the fluid to the patient;

defining a current pressure waveform based on the measured pressure; and

determining a characteristic of the catheter based on a comparison of at least a first waveform portion of the current pressure waveform to at least a second waveform portion of a previously-acquired pressure waveform associated with the catheter during delivery of the fluid.

2. The method of claim 1, further comprising:

obtaining a posture associated with the patient when the pressure associated with the catheter is measured; and

associating the determined characteristic of the catheter with the obtained posture.

3. The method of claim 1, wherein measuring the pressure comprises determining a time for the measured pressure to fall from a maximum pressure level to a signature pressure level, wherein the signature pressure level is a pressure when a pump stroke of the implantable medical fluid delivery device is not present.

4. The method of claim 1, further comprising identifying one or more characteristics indicative of one or more catheter malfunctions based on the determined characteristic of the catheter.

5. The method of claim 1, further comprising storing at least one of:

the determined characteristic of the catheter or the current pressure waveform.

6. The method of claim 1, wherein the previously-acquired pressure waveform corresponds to one or more waveforms corresponding to one or more malfunctions associated with the catheter.

7. The method of claim 1, wherein the current pressure waveform comprises a pressure decay profile for a current pump stroke of the implantable medical fluid delivery device, and the previously-acquired pressure waveform comprises a pressure decay profile for a previous pump stroke of the implantable medical fluid delivery device.

8. The method of claim 1, wherein the first waveform portion of the current waveform comprises first variations in pressure over a first time, and wherein the second waveform portion of the previously-acquired waveform comprises second variations in pressure over a second time.

9. The method of claim 1, wherein determining the characteristic of the catheter comprises determining a patency of the catheter based on the comparison of at least the first waveform portion of the current pressure waveform to at least the second waveform portion of the previously-acquired pressure waveform associated with the catheter during delivery of the fluid.

10. The method of claim 1, wherein determining the characteristic of the catheter comprises calculating a pressure decay time based on a maximum pressure value associated with the measured pressure.

11. The method of claim 10, wherein the decay time indicates a time required for the measured pressure to fall from the maximum pressure to a signature pressure level, wherein the signature pressure level is a pressure when a pump stroke of the implantable medical fluid delivery device is not present.

12. The method of claim 1, further comprising:

determining whether the catheter is functioning properly; and

measuring a current baseline pressure when the catheter is functioning properly.

13. The method of claim 12, wherein the current baseline pressure comprises a pressure decay profile for a pump stroke of the implantable medical fluid delivery device.

14. The method of claim 12, wherein the previously-acquired pressure waveform comprises a waveform acquired when the catheter is functioning properly.

15. The method of claim 12, further comprising:

measuring a new baseline pressure; and

determining whether to replace the current baseline pressure with the new baseline pressure.

16. A method of troubleshooting a catheter associated with an implantable medical fluid delivery device, the method comprising:

delivering a fluid from the implantable medical fluid delivery device through the catheter to a patient;

measuring a pressure associated with the catheter during the delivery of the fluid to the patient;

defining a current pressure waveform based on the measured pressure; and

displaying, on a display device, at least a portion of the current pressure waveform and at least a portion of a previously-acquired pressure waveform associated with the catheter during delivery of the fluid, for a user to determine a characteristic of the catheter based on a comparison of at least a portion of the current pressure waveform to at least a portion of a previously-acquired pressure waveform.

17. The method of claim 16, further comprising:

obtaining a posture associated with the patient when the pressure associated with the catheter is measured; and

associating the determined characteristic of the catheter with the obtained posture.

18. The method of claim 16, wherein measuring the pressure comprises determining a time for the measured pressure to fall from a maximum pressure level to a signature pressure level, wherein the signature pressure level is a pressure when a pump stroke of the implantable medical fluid delivery device is not present.

19. The method of claim 16, further comprising identifying one or more characteristics indicative of one or more catheter malfunctions based on the determined characteristic of the catheter.

20. The method of claim 16, wherein the previously-acquired pressure waveform corresponds to one or more waveforms corresponding to one or more malfunctions associated with the catheter.

21. The method of claim 16, wherein the current pressure waveform comprises a pressure decay profile for a current pump stroke of the implantable medical fluid delivery device, and the previously-acquired pressure waveform comprises a pressure decay profile for a previous pump stroke of the implantable medical fluid delivery device.

22. The method of claim 16, wherein the current baseline pressure comprises a pressure decay profile for a pump stroke of the implantable medical fluid delivery device.

23. The method of claim 16, further comprising:

displaying, on the display device, a plurality of selectable options, each of the selectable options representing a respective template waveform; and

receiving user input selecting one selectable option of the plurality of selectable options, wherein displaying, on the display device, at least the portion of the current pressure waveform and at least the portion of the previously-acquired pressure waveform further comprises, responsive to receiving the user input, displaying, on the display, the previously-acquired pressure waveform corresponding to the respective template waveform represented by the selected option.

24. The method of claim 23, wherein the respective template waveforms comprise at least two of:

a baseline waveform,

a disconnected waveform,

a migrated waveform,

an occluded waveform, or

a cut waveform.

25. The method of claim 16, further comprising:

determining whether the catheter is functioning properly; and

measuring a current baseline pressure when the catheter is functioning properly.

26. The method of claim 25, wherein the previously-acquired pressure waveform comprises a waveform acquired when the catheter is functioning properly.

27. The method of claim 25, further comprising:

measuring a new baseline pressure; and

determining whether to replace the current baseline pressure with the new baseline pressure.

28. The method of claim 25, wherein the current baseline pressure comprises a pressure decay profile for a pump stroke of the implantable medical fluid delivery device, and the previously-acquired pressure waveform comprises a pressure decay profile for a previous pump stroke of the implantable medical fluid delivery device.