Method and apparatus for automatically modifying delivery profile of drug delivery system

• US 8,221,395 B2
• Filed: 10/29/2007
• Issued: 07/17/2012
• Est. Priority Date: 03/02/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Shelton, Brian M., Lebel, Ronald J., Villegas, Danial H.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GILBERT, ANDREW M
• Application Number:
  US11/927,174
• Publication Number:
  US 20080177254A1
• Time in Patent Office: 1,723 Days
• Field of Search: 604/890.1, 604/891.1, 604/502, 604/503, 604/131, 604/151, 604/246
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

The present invention relates to an implantable drug delivery device which includes a fluid drug reservoir, a catheter, a controllable fluid transfer device, e.g., a pump or valve, and a drug delivery control means. The control means in accordance with the invention is configured to initially clear a first, or old, drug from the device based on the content of the Current Profile data containing a first, or old, delivery profile. After the old drug is cleared, then the control means automatically modifies the Current Profile data to match a second, or new, delivery profile for controlling delivery of a second, or new, drug.

Claims

1. A method of transferring fluid from an implantable drug delivery device that includes a reservoir, a fluid transfer device, and a catheter, the method comprising the steps of:

transferring a first drug from the implantable drug delivery device in accordance with a first delivery profile after the first drug has been evacuated from the reservoir and replaced by a second drug;

monitoring the quantity of the first drug within the implantable drug delivery device by monitoring activity of the fluid transfer device after the first drug has been evacuated from the reservoir and replaced by a second drug; and

transferring the second drug from the reservoir to the catheter in accordance with a second delivery profile, which is different than the first delivery profile, in response to the first drug being cleared from the implantable drug delivery device in accordance with the first delivery profile.

2. A method as claimed in claim 1, wherein

the step of transferring a first drug from the implantable drug delivery device comprises transferring the second drug from the reservoir to the catheter in accordance with the first delivery profile after the first drug has been evacuated from the reservoir and replaced by a second drug.

3. A method as claimed in claim 1, wherein

the step of transferring a first drug from the implantable drug delivery device in accordance with a first delivery profile includes controlling the fluid transfer device with a programmable microprocessor.

4. A method as claimed in claim 1, wherein

monitoring activity of the fluid transfer device comprises monitoring actuations of the fluid transfer device.

5. A method as claimed in claim 1, wherein

monitoring activity of the fluid transfer device comprises monitoring pump strokes.

6. A method as claimed in claim 1, wherein

monitoring activity of the fluid transfer device comprises monitoring activity of the fluid transfer device associated with the first delivery profile and any bolus delivery requests.

7. A method of transferring fluid from an implantable drug delivery device that includes a reservoir, a fluid transfer device, and a catheter, the method comprising the steps of:

transferring a first drug from the implantable drug delivery device in accordance with a first delivery profile, which specifies a schedule of at least two different flow rates during a delivery period of certain duration, after the first drug has been evacuated from the reservoir and replaced by a second drug;

monitoring the quantity of the first drug within the implantable drug delivery device by monitoring activity of the fluid transfer device; and

transferring the second drug from the reservoir to the catheter in accordance with a second delivery profile, which is different than the first delivery profile, in response to the first drug being cleared from the implantable drug delivery device in accordance with the first delivery profile.

8. An implantable drug delivery device, comprising:

a reservoir;

an outlet;

a fluid transfer device in fluid communication with the reservoir and the outlet; and

a controller configured to control the fluid transfer device to transfer fluid in accordance with a first delivery profile after a first drug has been evacuated from the reservoir, to monitor the activity of the fluid transfer device, and to control the fluid transfer device to transfer fluid in accordance with a second delivery profile, which is different than the first delivery profile, in response to the monitored activity of the fluid transfer device after the first drug has been evacuated from the reservoir and replaced by a second drug indicating that the first drug has been cleared from the implantable drug delivery device.

9. An implantable drug delivery device as claimed in claim 8, further comprising:

memory configured to store the first and second delivery profiles.

10. An implantable drug delivery device as claimed in claim 8, wherein the controller comprises a programmable microprocessor.

11. An implantable drug delivery device as claimed in claim 8, wherein the fluid transfer device comprises a pump.

12. An implantable drug delivery device as claimed in claim 8, wherein the controller is adapted to monitor activity of the fluid transfer device associated with the first delivery profile and any bolus delivery requests.

13. An implantable drug delivery device, comprising:

a reservoir;

an outlet;

a fluid transfer device in fluid communication with the reservoir and the outlet; and

a controller configured to control the fluid transfer device to transfer fluid in accordance with a first delivery profile, which specifies a schedule of at least two different flow rates during a delivery period of certain duration, after a first drug has been evacuated from the reservoir, to monitor the activity of the fluid transfer device, and to control the fluid transfer device to transfer fluid in accordance with a second delivery profile, which is different than the first delivery profile, in response to the monitored activity of the fluid transfer device after the first drug has been evacuated from the reservoir and replaced by a second drug indicating that the first drug has been cleared from the implantable drug delivery device.

14. An implantable drug delivery device that stores a total volume of fluid and includes a reservoir that stores a reservoir portion of the total volume of fluid, an outlet, and a fluid transfer device, wherein the improvement comprises:

a controller configured to monitor the actuations of the fluid transfer device, to actuate the fluid transfer device in accordance with a first delivery profile until the fluid transfer device has transferred a volume of fluid equal to the total volume of fluid less the reservoir portion, and to actuate the fluid transfer device in accordance with a second delivery profile, which is different than the first delivery profile, in response to a determination by the controller, based on monitored actuations of the fluid transfer device, that the fluid transfer device has transferred a volume of fluid equal to the total volume of fluid less the reservoir portion.

15. An implantable drug delivery device as claimed in claim 14, wherein the fluid transfer device comprises a pump.

16. An implantable drug delivery device as claimed in claim 15, wherein the controller is configured to monitor pump strokes.

17. An implantable drug delivery device as claimed in claim 14, further comprising:

memory configured to store the first and second delivery profiles.

18. An implantable drug delivery device as claimed in claim 14, wherein the controller comprises a programmable microprocessor.

19. An implantable drug delivery device that stores a total volume of fluid and includes a reservoir that stores a reservoir portion of the total volume of fluid, an outlet, and a fluid transfer device, wherein the improvement comprises:

a controller configured to monitor the actuations of the fluid transfer device, to actuate the fluid transfer device in accordance with a first delivery profile, which specifies a schedule of at least two different flow rates during a delivery period of certain duration, until the fluid transfer device has transferred a volume of fluid equal to the total volume of fluid less the reservoir portion, and to actuate the fluid transfer device in accordance with a second delivery profile, which is different than the first delivery profile, in response to a determination by the controller, based on monitored actuations of the fluid transfer device, that the fluid transfer device has transferred a volume of fluid equal to the total volume of fluid less the reservoir portion.

20. A method of operating an implantable drug delivery device including a reservoir, a fluid transfer device and a catheter, the method comprising:

transferring a first drug from the reservoir to the catheter in accordance with a first delivery profile which specifies a schedule of at least two different flow rates during a delivery period of certain duration;

transferring a second drug from the reservoir to the catheter in accordance with the at least two different flow rates of the first delivery profile, after the first drug has been evacuated from the reservoir in such a manner that a quantity of the first drug remains in the fluid transfer device and/or the catheter subsequent to the evacuation and after the reservoir has been filled with a second drug, so long as the first drug remains in the catheter; and

transferring the second drug from the reservoir to the catheter in accordance with a second delivery profile, which is different than the first delivery profile, after the first drug has been cleared from the catheter in accordance with the at least two different flow rates of the first delivery profile.

21. A method as claimed in claim 20, further comprising:

determining the quantity of the first drug remaining in the drug delivery device after the first drug as been evacuated from the reservoir by monitoring the activity of the fluid transfer device after the first drug has been evacuated from the reservoir.

22. A method as claimed in claim 21, wherein

the fluid transfer device comprises a pump;

and

monitoring the activity of the fluid transfer device after the first drug has been evacuated from the reservoir comprises monitoring pump strokes after the first drug has been evacuated from the reservoir.

23. A method as claimed in claim 20, wherein the period of certain duration comprises a twenty-four hour period.