Determining catheter status

• US 9,138,537 B2
• Filed: 11/23/2009
• Issued: 09/22/2015
• Est. Priority Date: 10/02/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): BUI, ANH T
• Application Number:
  US12/623,484
• Publication Number:
  US 20100069841A1
• Time in Patent Office: 2,129 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2202/0464 Cerebrospinal fluid
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile

Abstract

A method for determining the status of a catheter of an implanted infusion system, where the catheter is intended to deliver a fluid composition to CSF of a patient, includes monitoring catheter pressure, developing a pressure modulation profile based on the monitored pressure, and comparing the developed pressure modulation profile to a predetermined pressure profile. The predetermined pressure profile may be a profile of cerebrospinal fluid or a bolus infusion or withdrawal profile for the catheter. A determination of catheter status, such as properly functioning, occluded or leaky, can be made based on the comparison.

Claims

1. A method for determining status of a catheter of an implanted infusion system, wherein the infusion system includes an implantable infusion device operably coupled to the catheter, the catheter having a delivery region intended to be positioned in a target location of a patient, the delivery region being in communication with a lumen of the catheter, the implantable infusion device (i) configured to cause an agent stored in a reservoir to be delivered via the delivery region of the catheter through the lumen of the catheter, and (ii) having a port in communication with the lumen of the catheter, the method comprising:

percutaneously inserting a distal end of a probe into the port, the probe having a lumen, wherein the lumen of the probe is in communication with the catheter when the distal end of the probe is inserted into the port, and wherein the lumen of the probe is in communication with a pressure sensor;

measuring pressure via the pressure sensor;

developing a pressure modulation profile based on the measured pressure; and

comparing the developed pressure modulation profile to a predetermined pressure profile of the target location.

2. The method of claim 1, wherein the target location is the cerebrospinal fluid, and wherein the predetermined pressure profile comprises one or more of (i) a peak corresponding to the patient'"'"'s respiratory activity and (ii) peaks corresponding to the patient'"'"'s cardiac activity.

3. The method of claim 2, wherein the predetermined pressure profile comprises a plurality of peaks that repeat every two to ten seconds, corresponding to the patient'"'"'s respiratory rate, and a plurality of peaks that repeat every half second to second a half, corresponding to the patient'"'"'s cardiac activity.

4. The method of claim 1, further comprising determining whether a catheter complication exists based on the comparison between the developed pressure modulation profile to the predetermined pressure profile of cerebrospinal fluid.

5. The method of claim 4, wherein a catheter complication is determined to exist if the developed pressure modulation profile does not exhibit a predetermined characteristic of the predetermined pressure profile.

6. The method of claim 1, wherein the predetermined pressure profile comprises a plurality of peaks that repeat every two to ten seconds, corresponding to the patient'"'"'s respiratory activity.

7. The method of claim 1, wherein the predetermined pressure profile comprises a plurality of peaks that repeat every half second to second and a half, corresponding to the patient'"'"'s cardiac activity.

8. The method of claim 1, wherein the predetermined pressure profile comprises a profile associated with a cough or a valsalva maneuver.

9. The method of claim 1, wherein comparison of the pressure modulation profile and the predetermined pressure profile of cerebrospinal fluid is performed by a processor.

10. The method of claim 1, wherein the probe has an inner diameter defined by the lumen of the probe, wherein the catheter has an inner diameter defined by the lumen of the catheter, and wherein the inner diameter of the probe is 60% or less than 60% of the inner diameter of the probe.

11. The method of claim 1, wherein the probe is a 24 or higher gauge needle.

12. The method of claim 1, wherein the target location is selected from the patient'"'"'s cerebrospinal fluid and the patient'"'"'s vasculature.

13. A method for determining status of a catheter of an implanted infusion system, wherein the infusion system includes an implantable infusion device operably coupled to the catheter, the catheter having a delivery region for delivering fluid to a target location of a patient, the delivery region being in communication with a lumen of the catheter, the implantable infusion device (i) configured to cause an agent stored in a reservoir to be delivered via the delivery region of the catheter through the lumen of the catheter, and (ii) having a port in communication with the lumen of the catheter, the method comprising:

percutaneously inserting a distal end of a probe into the port, the probe having a lumen, wherein the lumen of the probe is in communication with the catheter when the distal end of the probe is inserted into the port, and wherein the lumen of the probe is in communication with a pressure sensor;

infusing or withdrawing a bolus of fluid into the lumen of the catheter;

measuring pressure created by the bolus via the pressure sensor;

developing a bolus pressure modulation profile based on the measured bolus pressure; and

comparing the developed bolus pressure modulation profile to a predetermined bolus pressure profile.

14. The method of claim 13, further comprising determining whether the catheter is occluded or has a leak based on the comparison of the developed bolus pressure modulation profile to the predetermined bolus pressure profile.

15. The method of claim 14, wherein the catheter is determined to be occluded if developed bolus pressure modulation profile has a pressure decay rate slower than the predetermined bolus pressure profile.

16. The method of claim 14, wherein the catheter is determined to have a leak if developed bolus pressure modulation profile has a pressure decay rate faster than the predetermined bolus pressure profile.

17. The method of claim 13, wherein comparison of the pressure modulation profile and the predetermined pressure profile of cerebrospinal fluid is performed by a processor.

18. The method of claim 13, wherein infusing or withdrawing a bolus of fluid into the lumen of the catheter comprises infusing a bolus of fluid into the lumen of the catheter.

19. The method of claim 13, wherein infusing or withdrawing a bolus of fluid into the lumen of the catheter comprises withdrawing a bolus of fluid from the lumen of the catheter.

20. The method of claim 13, wherein the probe has an inner diameter defined by the lumen of the probe, wherein the catheter has an inner diameter defined by the lumen of the catheter, and wherein the inner diameter of the probe is 60% or less than 60% of the inner diameter of the probe.