Device for drug delivery

• US 9,173,991 B2
• Filed: 07/02/2008
• Issued: 11/03/2015
• Est. Priority Date: 07/02/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali
• Primary Examiner(s): GILBERT, ANDREW M
• Application Number:
  US12/452,484
• Publication Number:
  US 20100145303A1
• Time in Patent Office: 2,680 Days
• Field of Search: 604/506, 604/66, 604/151, 604/503
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Delivery of more than one therapeutic fluid as a means to control symptoms of a health conditions is disclosed. More than one therapeutic fluid may be dispensed from more than one reservoir and delivered to a user'"'"'s body via one or more cannula that penetrate the skin. The therapeutic fluids may be delivered by action of one or more pumping mechanisms that may be controlled by a processor in a portable, ambulatory device. The therapeutic fluids may optionally be insulin and one or more of an amylin analog, pramlintide acetate and an exenatide, and the health condition may optionally be diabetes.

Claims

1. A portable ambulatory, skin securable therapeutic fluid delivery device for a user, the device comprising:

a disposable part housing accommodating at least a first reservoir containing a first therapeutic fluid and a second reservoir containing a second therapeutic fluid;

a reusable part housing accommodating a first pumping mechanism, a second pumping mechanism and a processor, said disposable part housing being removably coupleable to the reusable part housing, wherein the first pumping mechanism delivers the first therapeutic fluid from the first reservoir and the second pumping mechanism delivers the second fluid from the second reservoir, wherein the first and second pumping mechanisms have one or more shared parts, wherein the one or more shared parts comprise a gear and/or a motor;

a first cannula configured to be in fluid communication with the first reservoir, the first cannula being further configured to penetrate skin of the user to subcutaneously deliver the first therapeutic fluid; and

a second cannula configured to be in fluid communication with the second reservoir, the second cannula being further configured to penetrate the skin of the user to subcutaneously deliver the second therapeutic fluid,

wherein upon coupling of the reusable part housing and the disposable part housing the first and second pumping mechanisms are controlled by the processor to deliver concomitantly the first therapeutic fluid from the first reservoir to the first cannula at a first dosing rate and the second therapeutic fluid from the second reservoir to the second cannula at a second dosing rate.

2. The device as in claim 1, wherein the first dosing rate is different from the second dosing rate.

3. The device as in claim 1, further comprising a sensing apparatus in communication with the processor for determining an analyte concentration of the user.

4. The device as in claim 3, wherein the sensing apparatus determines glucose concentration data and communicates the glucose concentration data to the processor, in which the processor controls the first and/or the second dosing rate in response to the glucose concentration data.

5. The device as in claim 3, wherein the processor, the first and second pumping mechanisms and the sensing apparatus operate in one of:

a closed loop manner, a semi-closed loop manner, and an open loop manner.

6. The device as in claim 1, wherein the first therapeutic fluid comprises insulin.

7. The device as in claim 6, wherein the second therapeutic fluid comprises an amylin analog.

8. The device as in claim 7, wherein the amylin analog comprises pramlintide acetate.

9. The device as in claim 6, wherein the second therapeutic fluid comprises a glucagon.

10. The device as in claim 6, wherein the second therapeutic fluid comprises an exenatide.

11. The device as in claim 6, wherein the second therapeutic fluid comprises incretin mimetic.

12. The device as in claim 6, wherein the second therapeutic fluid comprises a biological active compound that complements the effects of insulin and being used as an adjunctive therapy to insulin delivery to alleviate postprandial glucose excursions.

13. The device as in claim 1, wherein a second dosing range is based on the first dosing rate.

14. The device as in claim 6, where in the second dosing rate is associated with an insulin total daily dose (TDD).

15. The device as in claim 1, wherein the first and/or second dosing rate is based on expected calorie and/or carbohydrate intake by the user.

16. The device as in claim 1, further comprising:

a cradle that comprises a first side adherable to the skin and a second side configured for connection and disconnection of at least the disposable part housing.

17. The device as in claim 16, wherein the cradle is configured to receive therethrough the first and second cannula.

18. The device as in claim 1, wherein at least one of the first and the second reservoirs is collapsible such that it changes volumes according to the volume of the therapeutic fluid contained therein.

19. The device as in claim 1, further comprising one or more buttons via which the user selects adjusting the first and/or second dosing rate.

20. A portable ambulatory, skin adherable infusion device for delivery of insulin and a therapeutic fluid to a user, the device comprising:

a disposable part housing accommodating at least a first reservoir containing insulin and a second reservoir containing a therapeutic fluid, said therapeutic fluid comprising at least one of;

an amylin analog, a glucagon, an exenatide and incretin mimetic;

a first cannula configured to be in fluid communication with the first reservoir, the first cannula being further configured to penetrate a user'"'"'s skin to subcutaneously deliver the insulin;

a second cannula configured to be in fluid communication with the second reservoir, the second cannula being further configured to penetrate the user'"'"'s skin to subcutaneously deliver the therapeutic fluid; and

a reusable part housing accommodating a peristaltic pump and a processor, said disposable part housing being removably coupleable to the reusable part housing,

wherein upon coupling of the reusable part housing and the disposable part housing said peristaltic pump is controlled by the processor to deliver concomitantly the insulin from the first reservoir to the first cannula at a first dosing rate and the therapeutic fluid from the second reservoir to the second cannula at a second dosing rate.

21. A method for delivery of insulin and a therapeutic fluid to a body of a user using a portable ambulatory, skin securable device, the method comprising:

applying to the body of the user a portable ambulatory, skin securable device which includes;

a disposable part housing accommodating at least a first reservoir containing insulin and a second reservoir containing a therapeutic fluid, said therapeutic fluid comprising at least one of;

an amylin analog, a glucagon, an exenatide and incretin mimetic,

a reusable part housing accommodating a first pumping mechanism, a second pumping mechanism and a processor, said disposable part housing being removably coupled to the reusable part housing, wherein the first pumping mechanism delivers the insulin from the first reservoir and the second pumping mechanism delivers the therapeutic fluid from the second reservoir, wherein the first and second pumping mechanisms have one or more shared parts, wherein the one or more shared parts comprise a gear and/or a motor,

a first cannula configured to be in fluid communication with the first reservoir, the first cannula being further configured to penetrate a user'"'"'s skin to subcutaneously deliver the insulin, and

a second cannula configured to be in fluid communication with the second reservoir, the second cannula being further configured to penetrate the user'"'"'s skin to subcutaneously deliver the therapeutic fluid;

controlling via the processor the first and second pumping mechanisms delivering concomitantly the insulin from the first reservoir to the first cannula at a first dosing rate and the therapeutic fluid from the second reservoir to the second cannula at a second dosing rate;

adjusting the second dosing rate based on data related to the insulin or to the first dosing rate; and

administering, via the first cannula and second cannula, concomitantly the insulin at the first dosing rate and said therapeutic fluid at the second dosing rate to the body of a user.

22. The method of claim 21, wherein the first dosing rate includes an insulin bolus component and adjusting of the first dosing rate including reducing the insulin bolus component.

23. The method of claim 21, wherein data related to the insulin or to the first dosing rate includes a percentage of an insulin total daily dose (TDD).

24. The method of claim 21, further comprising determining a tolerability of the user to insulin and/or the therapeutic fluid.

25. The method of claim 21, wherein the data related to insulin or to the first dosing rate is selected from a group consisting of:

consumable intake, amount of carbohydrates to be consumed, glycemic intake, body glucose level, whether the user is a first-time user.

26. The method of claim 21, wherein the administering the insulin and the therapeutic fluid occurs prior to a meal intake by the user.

27. The method of claim 21, wherein the therapeutic fluid is administered in a predetermined time interval.

28. A portable ambulatory, skin securable therapeutic fluid delivery device for a user, the device comprising:

a disposable part housing accommodating at least a first reservoir containing a first therapeutic fluid and a second reservoir containing a second therapeutic fluid;

a reusable part housing accommodating a first pumping mechanism, a second pumping mechanism and a processor, said disposable part housing being removably coupleable to the reusable part housing, wherein the first pumping mechanism delivers the first therapeutic fluid from the first reservoir and the second pumping mechanism delivers the second fluid from the second reservoir, wherein the first and second pumping mechanisms have one or more shared parts, wherein the one or more shared parts comprise a gear and/or a motor; and

at least one cannula configured to be in fluid communication with the first and second reservoirs, the at least one cannula being further configured to penetrate skin of the user to subcutaneously deliver both the first therapeutic fluid and the second therapeutic fluid,

wherein upon coupling of the reusable part housing and the disposable part housing the first and second pumping mechanisms are controlled by the processor to deliver concomitantly the first therapeutic fluid from the first reservoir to the at least one cannula at a first dosing rate and the second therapeutic fluid from the second reservoir to the at least one cannula at a second dosing rate.

29. A portable ambulatory, skin adherable infusion device for delivery of insulin and a therapeutic fluid to a user, the device comprising:

a disposable part housing accommodating at least a first reservoir containing insulin and a second reservoir containing a therapeutic fluid, said therapeutic fluid comprising at least one of;

an amylin analog, a glucagon, an exenatide and incretin mimetic;

at least one cannula configured to be in fluid communication with the first and second reservoirs, the at least one cannula being further configured to penetrate skin of the user to subcutaneously deliver both the insulin and the therapeutic fluid; and

a reusable part housing accommodating a peristaltic pump and a processor, said disposable part housing being removably coupleable to the reusable part housing,

wherein upon coupling of the reusable part housing and the disposable part housing said peristaltic pump is controlled by the processor to deliver concomitantly the insulin from the first reservoir to the at least one cannula at a first dosing rate and the therapeutic fluid from the second reservoir to the at least one cannula at a second dosing rate.

30. A method for delivery of insulin and a therapeutic fluid to a body of a user using a portable ambulatory, skin securable device, the method comprising:

applying to the body of the user a portable ambulatory, skin securable device which includes;

a disposable part housing accommodating at least a first reservoir containing insulin and a second reservoir containing a therapeutic fluid, said therapeutic fluid comprising at least one of;

an amylin analog, a glucagon, an exenatide and incretin mimetic,

a reusable part housing accommodating a first pumping mechanism, a second pumping mechanism and a processor, said disposable part housing being removably coupled to the reusable part housing, wherein the first pumping mechanism delivers the insulin from the first reservoir and the second pumping mechanism delivers the therapeutic fluid from the second reservoir, wherein the first and second pumping mechanisms have one or more shared parts, wherein the one or more shared parts comprise a gear and/or a motor, and

at least one cannula configured to be in fluid communication with the first and second reservoirs, and being further configured to penetrate skin of the user to subcutaneously deliver the insulin and the therapeutic fluid;

controlling via the processor the first and second pumping mechanisms delivering concomitantly the insulin from the first reservoir to the at least one cannula at a first dosing rate and the therapeutic fluid from the second reservoir to the at least one cannula at a second dosing rate;

adjusting the second dosing rate based on data related to the insulin or to the first dosing rate; and

administering, via the at least one cannula, concomitantly the insulin at the first dosing rate and said therapeutic fluid at the second dosing rate to the body of a user.