System, method and implantable device for delivery of therapeutic substance

• US 20030216682A1
• Filed: 03/24/2003
• Published: 11/20/2003
• 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.
• Granted Patent: US 8,128,616 B2
• Time in Patent Office: Days
• US Class Current: 604/65
• 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. If the second flow rate is higher than the first flow rate, 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 capable of transitioning 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 capable of delivering said first therapeutic substance to said patient at a known flow rate, calculating a bridge duration equal to said known volume divided by said known flow rate; and

controlling 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, beginning delivery of at least one of said first therapeutic substance and said second therapeutic substance 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, beginning delivery of said at least one of said first therapeutic substance and said second therapeutic substance 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, beginning delivery of at least one of said first therapeutic substance and said second therapeutic substance at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, beginning delivery of said at least one of said first therapeutic substance and said second therapeutic substance 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 capable of transitioning 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 capable of delivering said first drug to said patient at a known flow rate, calculating a bridge duration equal to said known volume of said catheter divided by said known flow rate; and

controlling 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, beginning delivery of at least one of said first drug and said second drug at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, beginning delivery of said at least one of said first drug and said second drug 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, beginning delivery of at least one of said first drug and said second drug at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, beginning delivery of said at least one of said first drug and said second drug 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 capable of transitioning 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 capable of delivering said first therapeutic substance to said patient at a known flow rate, calculating a bridge duration equal to said known volume divided by said known flow rate; and

controlling 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, beginning delivery of at least one of said first therapeutic substance and said second therapeutic substance 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, beginning delivery of said at least one of said first therapeutic substance and said second therapeutic substance 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, beginning delivery of at least one of said first therapeutic substance and said second therapeutic substance at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, beginning delivery of said at least one of said first therapeutic substance and said second therapeutic substance 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.

28. In a system for delivering a therapeutic substance at a flow rate to a patient, said system having a reservoir for holding said therapeutic substance operatively coupled to a delivery path of a known volume for delivering said therapeutic substance to said patient, a method of transitioning from delivery of a first therapeutic substance contained in said reservoir at a first flow rate to delivery of a second therapeutic substance at a second flow rate, comprising the steps of:

introducing said second therapeutic substance to said reservoir;

delivering at least one of said first therapeutic substance and said second therapeutic substance at a know flow rate;

calculating a bridge duration equal to said known volume divided by said known flow rate; and

then controlling said flow rate following said introducing step;

if said second flow rate is lower than said first flow rate, beginning delivery of at least one of said first therapeutic substance and said second therapeutic substance 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, beginning delivery of said at least one of said first therapeutic substance and said second therapeutic substance at said second flow rate at least as late as when said bridge duration is over.

29. A method as in claim 28 wherein if said known volume divided by said first flow rate if said second flow rate is equal to said first flow, continuing delivery of said at least one of said first therapeutic substance and said second therapeutic substance at said first flow rate.

30. A method as in claim 28 wherein:

if said second flow rate is lower than said first flow rate, beginning delivery of at least one of said first therapeutic substance and said second therapeutic substance at said second flow rate before said bridge duration is over; and

if said second flow rate is higher than said first flow rate, beginning delivery of said at least one of said first therapeutic substance and said second therapeutic substance at said second flow rate after said bridge duration is over.

31. A method as in claim 28 wherein said calculating step comprises calculating said bridge duration by dividing the sum of said known volume and a predetermined safety volume by said known rate.

32. A method as in claim 28 further comprising the step of removing any remaining volume of said first therapeutic substance from said reservoir.

33. A method as in claim 32 further comprising the step, taken before said removing step, of delivering said first therapeutic substance at said first flow rate.

34. A method as in claim 28 wherein said therapeutic substance is a fluid.

35. A method as in claim 34 wherein said therapeutic substance is a drug.

36. A method of transitional drug delivery between delivery of drug solutions at different concentrations or flow rates, said method comprising the following steps:

introducing a first solution containing at least one therapeutic agent into a reservoir of an implantable or ambulatory drug pump;

inputting into said programmer, or determining within said programmer or drug pump, a first flow rate or first pump speed;

delivering said first solution at said first flow rate or first pump speed from said reservoir through a fluid path to said patient, said fluid path having a known volume;

introducing a second solution containing at least one therapeutic agent into said reservoir;

inputting into said programmer, or determining within said programmer or drug pump, a second flow rate or second pump speed, said second flow rate or second pump speed being the same or different than said first flow rate or first pump speed;

if said first flow rate or first pump speed is higher than said second flow rate or second pump speed, continuing delivery at said first flow rate for an interval ending before said known volume of said fluid path is delivered, and then initiating delivery at said second flow rate.