Catheter malfunction determinations using physiologic pressure

• US 8,323,244 B2
• Filed: 03/30/2007
• Issued: 12/04/2012
• Est. Priority Date: 03/30/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Coffey, Robert J.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): HOLLOWAY, IAN KNOBEL
• Application Number:
  US11/731,356
• Publication Number:
  US 20080243074A1
• Time in Patent Office: 2,076 Days
• Field of Search: 600485-486, 600/488, 604/93.01
• US Class Current: 604/111
• 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 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 an implanted catheter used to deliver fluids to a selected internal delivery site is malfunctioning. The malfunctions may include that the infusion section of the catheter is not located at or has migrated away from the selected internal delivery site, is leaking, is blocked, etc. The determination is made by analyzing the pressure modulation of fluid within the catheter and determining whether the pressure of the fluid in the catheter is modulated by physiologic pressure changes experienced at the selected internal delivery site. The physiologic pressure modulations at the selected internal delivery site may be caused by, e.g., cardiac activity, respiration, changes in patient'"'"'s posture, etc.

Claims

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

measuring pressure of a fluid located within a lumen in a catheter implanted in a patient, wherein the lumen extends to an infusion section that is located at a selected internal delivery site in the cerebrospinal fluid of the patient;

developing a pressure modulation profile of the cerebrospinal fluid of the patient based on the measured pressure of the fluid in the lumen, wherein developing the pressure modulation profile is based on measuring the pressure of the fluid in the lumen when the fluid is stationary within the lumen;

comparing the pressure modulation profile to a selected pressure profile, wherein the selected pressure profile includes a physiological pressure modulation; and

determining the existence of a catheter malfunction if the pressure modulation profile does not include a feature of the physiological pressure modulation of the selected pressure profile.

2. 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.

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

4. A method according to claim 1, wherein the selected pressure profile is based at least in part on patient respiration.

5. A method according to claim 1, wherein the selected pressure profile is based at least in part on patient cardiac activity.

6. A method according to claim 1, wherein the selected internal delivery site is in the intrathecal space of the patient.

7. A method according to claim 6, wherein the selected pressure profile is based at least in part on changes in the pressure of the fluid as the patient moves between supine and upright postures.

8. A method according to claim 1, wherein the pressure modulation profile is developed based on pressure measurements obtained at only selected intervals.

9. A method according to claim 8, wherein the selected intervals are chosen based at least in part on the patient'"'"'s circadian rhythm.

10. A method according to claim 1, wherein the fluid in the lumen of the catheter comprises a therapeutic substance, and wherein the method further comprises delivering the therapeutic substance to the patient through the infusion section of the catheter.

11. A method according to claim 1, further comprising storing data representative of the pressure modulation profile in a data storage device before comparing the pressure modulation profile to a selected pressure profile.

32. A method according to claim 1, wherein the selected pressure profile comprises a peak corresponding to the patient'"'"'s cardiac activity.

33. A method according to claim 1, wherein the selected pressure profile comprises a peak corresponding to the patient'"'"'s respiratory activity.

34. A method according to claim 1, wherein the selected pressure profile comprises a peak corresponding to the patient'"'"'s cardiac activity and a peak corresponding to the patient'"'"'s respiratory activity.

12. A method of identifying the presence of a catheter malfunction in an implanted catheter, the method comprising:

measuring fluid pressure of a fluid located within a lumen in a catheter implanted in a patient, wherein the lumen extends to an infusion section that is located at a selected internal delivery site in the patient, wherein the selected internal delivery site is in the intrathecal space of the patient;

developing a pressure modulation profile based on the measured fluid pressure of the fluid in the lumen;

determining if the pressure modulation profile includes pressure modulation caused by patient cardiac activity by determining if the pressure modulation profile comprises a peak corresponding to the patient'"'"'s cardiac activity; and

determining that a catheter complication exists if the pressure modulation profile does not include the pressure modulation caused by the patient cardiac activity.

13. A method according to claim 12, wherein developing the pressure modulation profile is based on measuring the pressure of the fluid in the lumen when the fluid is stationary within the lumen.

14. A method according to claim 12, further comprising determining the existence of a catheter malfunction if the pressure modulation profile does not include pressure modulation caused by patient cardiac activity.

15. A method according to claim 14, further comprising providing an alert to the patient and/or a third party after determining the existence of the catheter malfunction.

16. A method according to claim 14, wherein the fluid comprises a therapeutic substance, and wherein the method further comprises:

delivering the therapeutic substance to the patient through the infusion section of the catheter; and

terminating delivery of the therapeutic substance to the patient after determining the existence of a catheter malfunction.

17. A method according to claim 12, wherein the pressure modulation profile is developed based on pressure measurements obtained at only selected intervals.

18. A method according to claim 17, wherein the selected intervals are chosen based at least in part on the patient'"'"'s circadian rhythm.

35. A method according to claim 12, wherein the method further includes determining if the pressure modulation profile includes pressure modulation caused by patient respiration by determining if the pressure modulation profile comprises a peak corresponding to the patient'"'"'s respiratory activity.

19. A method of identifying the presence of a catheter malfunction in an implanted catheter, the method comprising:

measuring fluid pressure of a fluid located within a lumen in a catheter implanted in a patient, wherein the lumen extends to an infusion section that is located at a selected internal delivery site in the patient, wherein the selected internal delivery site is in the intrathecal space of the patient;

developing a pressure modulation profile based on the measured fluid pressure of the fluid in the lumen;

determining if the pressure modulation profile includes pressure modulation caused by patient respiration by determining if the pressure modulation profile comprises a peak corresponding to the patient'"'"'s respiratory activity; and

determining that a catheter complication exists if the pressure modulation profile does not include the pressure modulation caused by the patient respiration.

20. A method according to claim 19, wherein developing the pressure modulation profile is based on measuring the pressure of the fluid in the lumen when the fluid is stationary within the lumen.

21. A method according to claim 19, further comprising determining the existence of a catheter malfunction if the pressure modulation profile does not include pressure modulation caused by patient respiration.

22. A method according to claim 21, further comprising providing an alert to the patient and/or a third party after determining the existence of the catheter malfunction.

23. A method according to claim 21, wherein the fluid comprises a therapeutic substance, and wherein the method further comprises:

delivering the therapeutic substance to the patient through the infusion section of the catheter; and

terminating delivery of the therapeutic substance to the patient after determining the existence of a catheter malfunction.

24. A method according to claim 19, wherein the pressure modulation profile is developed based on pressure measurements obtained at only selected intervals.

25. A method according to claim 24, wherein the selected intervals are chosen based at least in part on the patient'"'"'s circadian rhythm.

26. 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 an implantable infusion section 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 connected to receive the pressure signal from the pressure sensor, wherein the control electronics further;

develop a pressure modulation profile based on the fluid pressure measured in the delivery lumen;

determine if the pressure modulation profile includes a physiological pressure modulation caused by movement between supine and upright postures; and

determine that a catheter complication exists if the pressure modulation profile does not include the physiological pressure modulation caused by movement between supine and upright postures.

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

28. 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 an implantable infusion section 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 connected to receive the pressure signal from the pressure sensor, wherein the control electronics further;

develop a pressure modulation profile based on the fluid pressure measured in the delivery lumen;

determine if the pressure modulation profile includes a pressure modulation caused by patient cardiac activity by determining if the pressure modulation profile comprises a peak corresponding to the patient'"'"'s cardiac activity; and

determine that a catheter complication exists if the pressure modulation profile does not include the peak corresponding to modulations caused by the patient cardiac activity.

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

30. 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 an implantable infusion section 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 connected to receive the pressure signal from the pressure sensor, wherein the control electronics further;

develop a pressure modulation profile based on the fluid pressure measured in the delivery lumen;

determine if the pressure modulation profile includes pressure modulation caused by patient respiration by determining if the pressure modulation profile comprises a peak corresponding to the patient'"'"'s respiratory activity; and

determine that a catheter complication exists if the pressure modulation profile does not include the peak corresponding to the patient'"'"'s respiratory activity.

31. A system according to claim 30, wherein the pump mechanism, the reservoir, and the control electronics are contained within one or more implantable housings along with a power source.