Systems and methods of identifying catheter malfunctions using pressure sensing

• US 8,317,770 B2
• Filed: 03/30/2007
• Issued: 11/27/2012
• Est. Priority Date: 04/06/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Panken, Eric J.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US11/731,355
• Publication Number:
  US 20070270782A1
• Time in Patent Office: 2,069 Days
• Field of Search: 604/151, 604/65, 604/67, 604/500, 604/501
• US Class Current: 604/500
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/15 Detection of leaks
• 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

Abstract

Methods and systems for determining whether a catheter malfunction is present in a catheter by analyzing changes in the pressure of fluids being pumped through the delivery lumen of the catheter. The pressure changes that may be monitored may include, e.g., the peak pressure within the catheter and/or the pressure decay profile. The catheter malfunctions that may be determined using the methods and systems of the invention may include, e.g., leaks, blockages, the presence of gas bubbles, etc.

Claims

1. A method of identifying the presence of a catheter malfunction, the method comprising:

delivering pulses of a fluid into a delivery lumen of an implanted catheter;

measuring decay time after a selected pulse, wherein the decay time is the time required for pressure within the delivery lumen to fall below a selected threshold pressure value after a selected event corresponding to the selected pulse;

comparing the decay time to a selected decay time; and

determining the existence of a catheter malfunction in the form of a leak in the catheter if the decay time is below the selected decay time.

2. A method according to claim 1, further comprising:

assigning a timeout value to the decay time if the pressure within the delivery lumen does not fall below the selected threshold pressure value after a selected timeout time; and

determining the existence of a catheter malfunction in the form of a blockage in the delivery lumen if the decay time is assigned the timeout value.

3. A method according to claim 1, further comprising providing an alert to the patient and/or a third party after determining the existence of the catheter malfunction.

4. A method according to claim 1, further comprising terminating delivery of the fluid after determining the existence of the catheter malfunction.

5. A method according to claim 1, wherein the selected decay time comprises an average of a plurality of measured decay times obtained before the selected event.

6. A method according to claim 1, wherein the selected event comprises the time at which a signal is sent to a pump mechanism to deliver the selected pulse into the catheter.

7. A method according to claim 1, wherein the selected event comprises the time at which pressure in the delivery lumen reaches the selected threshold pressure before reaching a peak pressure after the selected pulse.

8. A method according to claim 1, further comprising determining a baseline pressure before the selected pulse and after a pulse that precedes the selected pulse.

23. An implantable infusion system comprising:

a pump mechanism fluidly coupled to a reservoir to receive fluid contained within the reservoir;

a catheter comprising a delivery lumen fluidly coupled to the pump mechanism, wherein the delivery lumen extends to a delivery region in the catheter;

a pressure sensor positioned to monitor fluid pressure within the delivery lumen of the catheter and provide a pressure signal representative of the fluid pressure; and

control electronics operably coupled to the pump mechanism and connected to receive the pressure signal from the pressure sensor, wherein the system, via the control electronics, pump mechanism and pressure sensor, is configured to carry out the method of claim 1.

24. A system according to claim 23, wherein the pump mechanism, the reservoir, and the control electronics are contained within one or more implantable housings along with a power source.

9. A method of identifying the presence of a catheter malfunction, the method comprising:

delivering pulses of a fluid into a delivery lumen of an implanted catheter;

measuring decay time after a selected pulse, wherein the decay time is the time required for pressure within the delivery lumen to fall below a selected threshold pressure value after a selected event corresponding to the selected pulse; and

assigning a timeout value to the decay time if the pressure within the delivery lumen does not fall below the selected threshold pressure value after a selected timeout time.

10. A method according to claim 9, further comprising determining the existence of a catheter malfunction in the form of a blockage in the delivery lumen if the decay time is assigned the timeout value.

11. A method according to claim 10, further comprising providing an alert to the patient and/or a third party after determining the existence of the catheter malfunction.

12. A method according to claim 10, further comprising terminating delivery of the fluid after determining the existence of the catheter malfunction.

13. A method according to claim 9, wherein the selected event comprises the time at which a signal is sent to a pump mechanism to deliver the selected pulse into the catheter.

14. A method according to claim 9, wherein the selected event comprises the time at which pressure in the delivery lumen reaches the selected threshold pressure before reaching a peak pressure after the selected pulse.

15. A method according to claim 9, further comprising determining a baseline pressure before the selected pulse and after a pulse that precedes the selected pulse.

25. An implantable infusion system comprising:

a pump mechanism fluidly coupled to a reservoir to receive fluid contained within the reservoir;

a catheter comprising a delivery lumen fluidly coupled to the pump mechanism, wherein

the delivery lumen extends to a delivery region in the catheter;

a pressure sensor positioned to monitor fluid pressure within the delivery lumen of the catheter and provide a pressure signal representative of the fluid pressure; and

control electronics operably coupled to the pump mechanism and connected to receive the pressure signal from the pressure sensor, wherein the system, via the control electronics, pump mechanism and pressure sensor, is configured to carry out the method of claim 9.

26. A system according to claim 25, wherein the pump mechanism, the reservoir, and the control electronics are contained within one or more implantable housings along with a power source.

16. A method of identifying the presence of a catheter malfunction, the method comprising:

delivering pulses of a fluid into a delivery lumen of an implanted catheter;

measuring peak pressure within the delivery lumen after a selected pulse;

comparing the measured peak pressure to a selected peak pressure value; and

determining the existence of a catheter malfunction in the form of a disconnected catheter if the measured peak pressure value is below the selected peak pressure value.

17. A method according to claim 16, further comprising providing an alert to the patient and/or a third party after determining the existence of the catheter malfunction.

18. A method according to claim 16, further comprising terminating delivery of the therapeutic substance after determining the existence of the catheter malfunction.

19. A method according to claim 16, wherein the selected peak pressure value comprises an average of a plurality of measured peak pressures obtained before the selected pulse.

20. A method according to claim 16, wherein the selected peak pressure value comprises a rolling average of a plurality of measured peak pressure values obtained before the selected pulse.

21. A method according to claim 16, further comprising determining a baseline pressure before the selected pulse and after a pulse that precedes the selected pulse.

27. An implantable infusion system comprising:

a pump mechanism fluidly coupled to a reservoir to receive fluid contained within the reservoir;

a catheter comprising a delivery lumen fluidly coupled to the pump mechanism, wherein the delivery lumen extends to a delivery region in the catheter;

a pressure sensor positioned to monitor fluid pressure within the delivery lumen of the catheter and provide a pressure signal representative of the fluid pressure; and

control electronics operably coupled to the pump mechanism and connected to receive the pressure signal from the pressure sensor, wherein the system, via the control electronics, pump mechanism and pressure sensor, is configured to carry out the method of claim 16.

28. A system according to claim 27, wherein the pump mechanism, the reservoir, and the control electronics are contained within one or more implantable housings along with a power source.

22. A method of determining the presence of a catheter malfunction, the method comprising:

delivering pulses of the fluid into a delivery lumen of the catheter;

measuring peak pressure within the delivery lumen after a selected pulse;

comparing the measured peak pressure to a selected peak pressure value;

determining the existence of a catheter malfunction in the form of a disconnected catheter if the measured peak pressure value is below the selected peak pressure value after comparing the measured peak pressure to the selected peak pressure;

measuring decay time after a selected pulse, wherein the decay time is the time required for pressure within the delivery lumen to fall below a selected threshold pressure value after a selected event corresponding to the selected pulse;

assigning a timeout value to the decay time if the pressure within the delivery lumen does not fall below the selected threshold pressure value after a selected timeout time;

comparing the decay time to a selected decay time after measuring the decay time;

determining the existence of a catheter malfunction in the form of a leak in the catheter if the decay time is below the selected decay time; and

determining the existence of a catheter malfunction in the form of a blockage in the delivery lumen if the decay time is at the timeout value.