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

• US 7,347,854 B2
• Filed: 02/28/2005
• Issued: 03/25/2008
• Est. Priority Date: 03/02/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Infusion Systems, LLC
• Inventors: Villegas, Danial H., Lebel, Ronald J., Shelton, Brian M.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): MOULTON, ELIZABETH ROSE
• Application Number:
  US11/069,573
• Publication Number:
  US 20050197649A1
• Time in Patent Office: 1,121 Days
• Field of Search: 604/66, 604/890.1, 604/891.1, 604/503, 604/93.01, 604/65, 604/502, 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 operating an implantable drug delivery that includes a reservoir, a fluid transfer device, and a catheter, said method comprising the steps of:

filling said reservoir with a first drug;

controllably transferring said first drug from said reservoir to said catheter and a body site in accordance with a first delivery profile specifying a schedule of at least two different flow rates during a delivery period of certain duration;

evacuating said first drug from said reservoir;

filling said reservoir with a second drug;

providing a second delivery profile specifying a schedule of flow rates for transferring said second drug to said catheter;

determining the quantity of first drug remaining by monitoring activity of the fluid transfer device, and continuing to transfer the remaining quantity of said first drug in said delivery device to said body site in accordance with said first delivery profile, after evacuating said reservoir; and

initiating controllable transfer of said second drug from said reservoir to said catheter in accordance with said second delivery profile after said remaining quantity of said first drug has been cleared from said device in accordance with the first delivery profile.

2. The method of claim 1 wherein said step of controllably transferring said first drug from said reservoir includes the step of:

operating a programmable microprocessor to control a controllable fluid transfer device.

3. The method of claim 1 wherein said step of determining the quantity of first drug remaining includes the step of calculating the difference between a stored quantity of said first drug and a quantity of drug transferred from said delivery device after evacuation of said reservoir.

4. The method of claim 1, wherein the delivery period of certain duration comprises a twenty-four hour period.

5. The method of claim 1, wherein the step of determining the quantity of first drug remaining by monitoring activity of the fluid transfer device comprises the step of determining the quantity of first drug remaining by monitoring pump strokes.

6. An implantable fluid delivery device comprising:

a reservoir for storing a fluid;

a catheter for transferring fluid from said reservoir to a selected body site, said catheter having a proximal end for receiving fluid from said reservoir and a distal end for delivering fluid to said body site;

a controllable pump coupling said reservoir to said catheter proximal end;

a controller for storing a current delivery profile;

means for introducing a first fluid into said reservoir;

means for storing a first delivery profile, including at least two different flow rates during different intervals within a period of certain duration, in said controller as said current delivery profile for specifying a schedule of flow rates for said first fluid;

means for supplying a second delivery profile to said controller specifying a schedule of flow rates for a second fluid;

means for determining the quantity of said first fluid remaining in said delivery device by monitoring pump actuations;

said controller being operable to control said pump in accordance with said current delivery profile to deliver said first fluid to said body site at rates specified by said first delivery profile and to adopt said second delivery profile as said current delivery profile in response a determination by the means for determining that said first fluid has been fully cleared from said delivery device in accordance with the first delivery profile.

7. The delivery device of claim 6 wherein said controller comprises a programmable microprocessor.

8. The delivery device of claim 6 further including means for selectively evacuating fluid from said reservoir.

9. The delivery device of claim 6 in combination with an external programmer for supplying said second delivery profile.

10. The delivery device of claim 9 wherein said second delivery profile is applicable to a period of certain duration and specifies at least two different flow rates during different intervals within said period.

11. The delivery device of claim 6 wherein said means for determining the quantity of first fluid remaining in said delivery device includes means for calculating the difference between a quantity of fluid stored in said delivery device and a quantity of fluid transferred by said pump.

12. The delivery device of claim 6, wherein the period of certain duration comprises a twenty-four hour period.

13. An implantable drug delivery device comprising:

a reservoir for storing a fluid drug;

means for introducing a first fluid into said reservoir;

a catheter for transferring a fluid from said reservoir to a selected body site, said catheter having a proximal end for receiving fluid from said reservoir and a distal end for delivering fluid to said body site;

a controllable fluid transfer device coupling said reservoir to said catheter proximal end;

a controller for storing a current delivery profile;

means for storing a first delivery profile in said controller as said current delivery profile;

means for evacuating said first fluid from said reservoir and introducing a second fluid into said reservoir;

means for supplying a second delivery profile for a second fluid;

means for determining the quantity of said first fluid transferred from said delivery device in accordance with said first delivery profile and any bolus delivery requests subsequent to an evacuation of the first fluid from the reservoir;

means for operating said fluid transfer device in accordance with said current delivery profile to deliver said first fluid through said catheter to said body site at the schedule of flow rates specified by said first delivery profile subsequent to an evacuation of said first fluid from said reservoir; and

means for adopting said second delivery profile as said current delivery profile in response to a determination by the means for determining that said first fluid being fully cleared from said delivery device.

14. The delivery device of claim 13 wherein said fluid transfer device comprises at least one pump.

15. The delivery device of claim 13 wherein said fluid transfer device comprises at least one valve.

16. The delivery device of claim 13 wherein at least one of the first and second delivery profiles defines a schedule of at least two different flow rates for a period of certain duration.

17. The delivery device of claim 13 wherein said controller includes a programmable microprocessor.

18. The delivery device of claim 13 in combination with an external programmer selectively operable to supply a delivery profile to said delivery device.

19. The delivery device of claim 16, wherein the delivery period of certain duration comprises a twenty-four hour period.

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

transferring a first drug from the reservoir to the catheter in accordance with a first delivery profile;

transferring a second drug from the reservoir to the catheter in accordance with the first delivery profile and at least one bolus delivery request, 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 first delivery profile and the at least one bolus delivery request.

21. A method as claimed in claim 20, wherein at least one of the first and second delivery profiles specifies a schedule of at least two different flow rates during portions of a period of certain duration.

22. A method as claimed in claim 20, further comprising the step of:

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.

23. A method as claimed in claim 21, wherein the period of certain duration comprises a twenty-four hour period.

24. A method as claimed in claim 22, wherein

the fluid transfer device comprises a pump;

and

the step of 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.