Determining catheter status

• US 10,357,620 B2
• Filed: 09/21/2015
• Issued: 07/23/2019
• 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): Price, Nathan R
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US14/860,198
• Publication Number:
  US 20160074600A1
• Time in Patent Office: 1,401 Days
• 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 system for determining whether an implanted infusion system has catheter complications, the implantable infusion system comprising a catheter access port in communication with a lumen of a catheter, the lumen of the catheter having an inner diameter defined by the lumen, the system comprising:

a probe having a lumen defining an inner diameter, wherein the inner diameter of the probe is less than or equal to 60% of the inner diameter of the catheter, wherein the probe is configured to be percutaneously inserted into the catheter access port;

a pressure sensor operably coupled to the probe and configured to measure pressure in the lumen of the probe; and

a processor configured to identify pressure changes associated with a physiological event by comparing pressure measured via the pressure sensor to a pressure profile associated with the physiological event.

2. A system according to claim 1, further comprising a tube operably coupled to the probe, the tube having a lumen defining an inner diameter, wherein the inner diameter of the probe is less than or equal to 60% of the inner diameter of the tube.

3. A system according to claim 1, further comprising a monitor configured to display a representation of pressure measured by the pressure sensor.

4. A system according to claim 1, further comprising a bolus delivery apparatus configured to deliver or withdraw a bolus of fluid through the lumen of the probe.

5. A system according to claim 4, wherein the processor is configured to compare pressure measured via the pressure sensor to a predetermined bolus pressure profile for the catheter.

6. A system according to claim 5, wherein the processor is configured to determine that the catheter is occluded if a developed bolus pressure modulation profile has a pressure decay rate slower than the predetermined bolus pressure profile.

7. A system according to claim 5, wherein the processor is configured to determine that the catheter has a leak if a developed bolus pressure modulation profile has a pressure decay rate faster than the predetermined bolus pressure profile.

8. A system according to claim 1, the pressure profile associated with the physiological event comprising one or both of (i) a peak corresponding to the patient'"'"'s respiratory activity and (ii) a peak corresponding to the patient'"'"'s cardiac activity.

9. A system according to claim 8, wherein the pressure profile associated with the physiological event 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 and a half, corresponding to the patient'"'"'s cardiac activity.

10. A system according to claim 8, wherein the processor is configured to determine that a catheter complication exists if a profile of pressure measured via the pressure sensor does not exhibit a predetermined characteristic of the pressure profile associated with the physiological event.

11. A system according to claim 1, wherein the pressure profile associated with the physiological event comprises a cough or a Valsalva maneuver.

12. A system according to claim 1, wherein the probe comprises a 24 or higher gauge needle.

13. A system for determining whether an implanted infusion system has catheter complications, the implantable infusion system comprising a catheter access port in communication with a lumen of a catheter, the system comprising:

a probe configured to be percutaneously inserted into the catheter access port;

a pressure sensor operably coupled to the probe and configured to measure pressure in the lumen of the probe; and

a processor configured to identify pressure changes associated with a physiological event by comparing pressure measured via the pressure sensor to a pressure profile associated with the physiological event.

14. A system according to claim 13, further comprising a bolus delivery apparatus configured to deliver or withdraw a bolus of fluid through the lumen of the probe.

15. A system according to claim 14, wherein the processor is configured to compare pressure measured via the pressure sensor to a predetermined bolus pressure profile for the catheter.

16. A system according to claim 15, wherein the processor is configured to determine that the catheter is occluded if a developed bolus pressure modulation profile has a pressure decay rate slower than the predetermined bolus pressure profile.

17. A system according to claim 15, wherein the processor is configured to determine that the catheter has a leak if a developed bolus pressure modulation profile has a pressure decay rate faster than the predetermined bolus pressure profile.

18. A system according to claim 13, the pressure profile associated with the physiological event comprising one or both of (i) a peak corresponding to the patient'"'"'s respiratory activity and (ii) a peak corresponding to the patient'"'"'s cardiac activity.

19. A system according to claim 18, wherein the processor is configured to determine that a catheter complication exists if a profile of pressure measured via the pressure sensor does not exhibit a predetermined characteristic of the pressure profile associated with the physiological event.

20. A system according to claim 13, wherein the pressure profile associated with the physiological event comprises a cough or a Valsalva maneuver.