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

• US 20050197649A1
• Filed: 02/28/2005
• Published: 09/08/2005
• Est. Priority Date: 03/02/2004
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medical Research Product B, A California Corporation
• Inventors: Lebel, Ronald J., Shelton, Brian M., Villegas, Danial H.
• Granted Patent: US 7,347,854 B2
• Time in Patent Office: Days
• US Class Current: 604/890.1
• 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 device for transferring a drug from a reservoir to a catheter for delivery to a body site, said method including:

filling said reservoir with a first drug;

controllably transferring said first drug from said reservoir to said catheter and body site in accordance with a first delivery profile specifying a schedule of flow rates;

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;

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.

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

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

3. The method of claim 1 wherein said step of continuing to transfer the remaining quantity of said first drug includes the step of determining the quantity of first drug remaining after evacuating said reservoir.

4. The method of claim 3 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.

5. The method of claim 1 wherein said first delivery profile specifies at least two different flow rates during a period of certain duration.

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 fluid transfer device 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 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;

said controller being operable to control said fluid transfer device 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

wherein

said controller is operable to adopt said second delivery profile as said current delivery profile after said first fluid has been deared from said delivery device.

7. The delivery device of claim 6 wherein said fluid transfer device comprises at least one pump.

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

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

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

11. The delivery device of claim 10 wherein each of said delivery profiles is applicable to a period of certain duration and specifies two or more different flow rates with respect to different intervals within said period.

12. 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 fluid transfer device.

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 where said first delivery profile specifies a schedule of flow rates fro said first fluid;

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

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

means for determining the quantity of said first fluid remaining in said delivery device;

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; and

means for recognizing when said first fluid has been cleared from said delivery device; and

means for adopting said second delivery profile as said current delivery profile after said first fluid has been 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 each delivery profile defines a schedule of 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 13 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 fluid transfer device.