System, method and implantable device for delivery of therapeutic substance

• US 8,128,616 B2
• Filed: 03/24/2003
• Issued: 03/06/2012
• Est. Priority Date: 03/27/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Junker, Douglas P.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US10/400,152
• Publication Number:
  US 20030216682A1
• Time in Patent Office: 3,270 Days
• Field of Search: 6048901-8921, 604 65- 67, 604/300, 607/60, 600/300
• 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 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 5/16877 Adjusting flow; Devices for setting a flow rate
• 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

A system and method for transitioning between therapeutic substances to be delivered at different flow rates to a patient. The first therapeutic substance is delivered to the patient at a known flow rate, a bridge duration equal to the known volume divided by the known flow rate is calculated; and the flow rate is controlled following introduction of a second therapeutic substance into the reservoir. If the second flow rate is lower than the first flow rate, delivery is begun of at least one of the first therapeutic substance and the second therapeutic substance at the second flow rate at least as soon as the bridge duration is over. Otherwise, delivery is begun of the at least one of the first therapeutic substance and the second therapeutic substance at the second flow rate at least as late as when the bridge duration is over.

Claims

1. A system for delivering a therapeutic substance at a flow rate to a patient, comprising:

a reservoir for holding said therapeutic substance;

a delivery path of a known volume operatively coupled to said reservoir and adapted to be operatively coupled to said patient;

an adjustable metering device arranged along said delivery path capable of controlling a flow rate of said therapeutic substance to said patient;

a controller operatively coupled to said adjustable metering device, said controller being configured to transition from delivery of a first therapeutic substance at a first flow rate to delivery of a second therapeutic substance at a second flow rate;

said controller being configured to deliver said first therapeutic substance to said patient at a known flow rate, being configured to calculate a bridge duration equal to said known volume divided by said known flow rate; and

being configured to control said adjustable metering device in order to control said flow rate following introduction of said second therapeutic substance into said reservoir such that;

if said second flow rate is lower than said first flow rate, said adjustable metering device being configured to control said flow rate at said second flow rate at least as soon as said bridge duration is over; and

if said second flow rate is higher than said first flow rate, said adjustable metering device being configured to control said flow rate at said second flow rate at least as late as when said bridge duration is over.

2. A system as in claim 1 wherein said known flow rate is equal to said first flow rate.

3. A system as in claim 1 wherein if said known volume divided by said first flow rate if said second flow rate is equal to said first flow, said system continues delivery of said at least one of said first therapeutic substance and said second therapeutic substance at said first flow rate.

4. A system as in claim 1 wherein:

if said second flow rate is lower than said first flow rate, said adjustable metering device controls said flow rate at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, said adjustable metering device controls said flow rate at said second flow rate after said bridge duration is over.

5. A system as in claim 1 wherein said controller calculates said bridge duration by dividing the sum of said known volume and a predetermined safety volume by said known rate.

6. A system as in claim 1 wherein said therapeutic substance is a fluid.

7. A system as in claim 6 wherein said therapeutic substance is a drug.

8. A system as in claim 1 wherein said reservoir, said delivery path and said adjustable metering device are contained in an implantable drug pump.

9. A system as in claim 8 wherein said controller is contained in an external programmer and wherein said external programmer and said implantable drug pump operatively communicate with each other.

10. A system as in claim 8 wherein said adjustable metering device is a pump.

11. A system as in claim 8 wherein said delivery path comprises a catheter.

12. A system for delivering a fluid drug at a flow rate to a patient, comprising:

a reservoir for holding said drug;

a catheter of a known volume operatively coupled to said reservoir and adapted to be operatively coupled to said patient;

pump arranged along said delivery path capable of controlling a flow rate of said drug to said patient;

a controller operatively coupled to said adjustable metering device, said controller being configured to transition from delivery of a first drug at a first concentration delivered at a first flow rate to delivery of a second drug at a second concentration at a second flow rate;

said controller being configured to deliver said first drug to said patient at a known flow rate, being configured to calculate a bridge duration equal to said known volume of said catheter divided by said known flow rate; and

being configured to control said pump in order to control said flow rate following introduction of said second drug into said reservoir such that;

if said second flow rate is lower than said first flow rate, said adjustable metering device being configured to control said flow rate at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, said adjustable metering device being configured to control said flow rate at said second flow rate after said bridge duration is over.

13. A system as in claim 12 wherein said known flow rate is equal to said first flow rate.

14. A system as in claim 12 wherein if said known volume divided by said first flow rate if said second flow rate is equal to said first flow, said system continues delivery of said at least one of said first drug and said second drug at said first flow rate.

15. A system as in claim 12 wherein:

if said second flow rate is lower than said first flow rate, said adjustable metering device controls said flow rate at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, said adjustable metering device controls said flow rate at said second flow rate after said bridge duration is over.

16. A system as in claim 12 wherein said controller calculates said bridge duration by dividing the sum of said known volume and a predetermined safety volume by said known rate.

17. A system as in claim 12 wherein said reservoir and said adjustable metering device are contained in an implantable drug pump.

18. A system as in claim 17 wherein said controller is contained in an external programmer and wherein said external programmer and said implantable drug pump operatively communicate with each other.

19. An implantable device for delivering a therapeutic substance at a flow rate to a patient, comprising:

a reservoir for holding said therapeutic substance;

a delivery path of a known volume operatively coupled to said reservoir and adapted to be operatively coupled to said patient;

an adjustable metering device arranged along said delivery path capable of controlling a flow rate of said therapeutic substance to said patient;

a controller operatively coupled to said adjustable metering device, said controller being configured to transition from delivery of a first therapeutic substance at a first flow rate to delivery of a second therapeutic substance at a second flow rate;

said controller being configured to deliver said first therapeutic substance to said patient at a known flow rate, being configured to calculate a bridge duration equal to said known volume divided by said known flow rate; and

being configured to control said adjustable metering device in order to control said flow rate following introduction of said second therapeutic substance into said reservoir such that;

if said second flow rate is lower than said first flow rate, said adjustable metering device being configured to control said flow rate at said second flow rate at least as soon as said bridge duration is over; and

if said second flow rate is higher than said first flow rate, said adjustable metering device being configured to control said flow rate at said second flow rate at least as late as when said bridge duration is over.

20. An implantable device as in claim 19 wherein said known flow rate is equal to said first flow rate.

21. An implantable device as in claim 19 wherein if said known volume divided by said first flow rate if said second flow rate is equal to said first flow, said implantable device continues delivery of said at least one of said first therapeutic substance and said second therapeutic substance at said first flow rate.

22. An implantable device as in claim 19 wherein:

if said second flow rate is lower than said first flow rate, said adjustable metering device controls said flow rate at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, said adjustable metering device controls said flow rate at said second flow rate after said bridge duration is over.

23. An implantable device as in claim 19 wherein said controller calculates said bridge duration by dividing the sum of said known volume and a predetermined safety volume by said known rate.

24. An implantable device as in claim 19 wherein said therapeutic substance is a fluid.

25. An implantable device as in claim 24 wherein said therapeutic substance is a drug.

26. An implantable device as in claim 19 wherein said adjustable metering device is a pump.

27. An implantable device as in claim 19 wherein said delivery path comprises a catheter.