System and method for intraparenchymal drug infusion

• US 7,794,443 B2
• Filed: 10/24/2006
• Issued: 09/14/2010
• Est. Priority Date: 10/24/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Nelson, Brian D., Adams, Matthew H., Gronda, Ann M.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): Hall; Deanna K
• Application Number:
  US11/552,400
• Publication Number:
  US 20080097287A1
• Time in Patent Office: 1,421 Days
• Field of Search: 604/65, 604/67, 604/503, 604/505, 604/890.1, 604/891.1
• US Class Current: 604/505
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16854 by monitoring line pressure

Abstract

A system for performing an intraparenchymal drug infusion including a pump device, a delivery tube, a sensor, and a processor. The tube is fluidly coupled to the pump device, establishing an infusate pathway from the pump to an infusate exit port of the delivery tube. The sensor is positioned to sense a parameter indicative of pressure in the infusate pathway. Finally, the processor is programmed to generate information indicative of infusate delivery effectiveness of a drug infusion procedure based upon information from the sensor. In some embodiments, the processor generates a net infusion pressure profile, such as a pressure-time curve, and prompts display of the pressure profile to a neurosurgeon for subsequent evaluation of infusate delivery effectiveness.

Claims

1. A method of performing an intraparenchymal drug infusion procedure, the method comprising:

positioning an infusate exit port of a delivery tube at a target site;

infusing the target site with the drug by pumping the drug through an infusate pathway formed by the delivery tube;

monitoring pressure information indicative of an internal pressure of the infusate pathway while infusing the target site;

reviewing the monitored pressure for possible existence of a rising pressure period, a declining pressure period, and a substantially constant pressure period; and

evaluating infusate delivery effectiveness, including whether infusate was delivered to the target site and whether a therapeutically effective volume of distribution remains at the target site, based upon the monitored pressure and the review.

2. The method of claim 1, wherein reviewing the monitored pressure includes:

generating a pressure profile based upon the monitored pressure.

3. The method of claim 2, wherein the pressure profile is a pressure-time curve.

4. The method of claim 2, wherein evaluating infusate delivery effectiveness further includes:

displaying the pressure profile to a user.

5. The method of claim 2, wherein generating a pressure profile includes:

determining baseline pressure information relating to the target site;

formulating a net infusion pressure profile as a function of the monitored pressure information and the baseline pressure information.

6. The method of claim 5, wherein the baseline pressure information is a function of a static pressure difference between a sensor generating the monitored pressure information and the infusate exit port, and of an interstitial fluid pressure.

7. The method of claim 5, wherein the net infusion pressure profile is formulated based upon a difference between the monitored pressure information and the baseline pressure information.

8. The method of claim 1, wherein the evaluation is based upon whether a pressure profile corresponding with the monitored pressure information is indicative of a steady state pressure corresponding with an expected steady state pressure.

9. The method of claim 1, wherein the evaluation is based upon whether a pressure profile corresponding with the monitored pressure information is indicative of an absence of a steady state pressure being achieved.

10. The method of claim 1, wherein evaluating infusate delivery effectiveness includes determining whether the infused drug has leaked out of tissue at the target site based upon whether a pressure profile corresponding with the monitored pressure information is indicative of a steady state pressure approximating a baseline pressure of the target site.

11. The method of claim 1, wherein evaluating infusate delivery effectiveness includes:

maintaining a library of reference pressure profiles indicative of successful drug infusions;

selecting a reference pressure profile from the library;

generating a current pressure profile based upon the monitored pressure; and

comparing the current pressure profile with the selected reference pressure profile.

12. The method of claim 1, wherein evaluating infusate delivery effectiveness includes determining whether desired tissue was infused.

13. The method of claim 12, wherein the target site is a brain of the patient, and evaluating infusate delivery effectiveness includes determining whether white matter or grey matter was infused.

14. The method of claim 1, wherein the target site is intracerebral tissue.

15. The method of claim 2, further comprising:

deactivating the pump following completion of delivering the drug to the delivery tube;

wherein evaluating infusate delivery effectiveness occurs after the steps of deactivating the pump and generating a pressure profile.

16. The method of claim 11, further comprising:

simultaneously displaying the current pressure profile and the selected reference pressure profile to a user.

17. The method of claim 16, wherein simultaneously displaying includes displaying the current pressure profile and the selected reference pressure profile in graph form.

18. The method of claim 1, wherein evaluating infusate delivery effectiveness includes evaluating whether infusate has backflowed along an exterior wall of the delivery tube.