DEVICE FOR DRUG DELIVERY

• US 20100145303A1
• Filed: 07/02/2008
• Published: 06/10/2010
• 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: Shapira, Gali, Yodfat, Ofer
• Granted Patent: US 9,173,991 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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 therapeutic fluid delivery device having a form factor that permits ambulatory use by a user, the device comprising:

a first reservoir for containing a first therapeutic fluid;

a second reservoir for containing a second therapeutic fluid;

at least one cannula in fluid communication with the first and/or second reservoir, the at least one cannula being disposed to penetrate the user'"'"'s skin to deliver the first and/or the second therapeutic fluid subcutaneously at a dosing rate;

at least one pumping mechanism that delivers the first therapeutic fluid from the first reservoir at a first dosing rate and delivers the second therapeutic fluid from the second reservoir at a second dosing rate to the at least one cannula and into the user; and

a processor that controls the at least one pumping mechanism.

2. A portable therapeutic fluid delivery device as in claim 1, wherein the at least one cannula comprises a first cannula in fluid communication with the first reservoir and a second cannula in fluid communication with the second reservoir.

3. A portable therapeutic fluid delivery device as in any of claims 1 or 2, wherein the first dosing rate is different from the second dosing rate.

4. A portable therapeutic fluid delivery device as in any of claims 1 to 3, wherein the at least one pumping mechanism comprises a first pumping mechanism and a second pumping mechanism, the first pumping mechanism delivering the first fluid from the first reservoir and the second pumping mechanism delivering the second fluid from the second reservoir.

5. A portable therapeutic fluid delivery device as in any of claims 1 to 4, further comprising a remote control unit that comprises a user interface for entering commands and/or receiving data from the processor.

6. A portable therapeutic fluid delivery device as in claim 5, further comprising a wireless communication module and wherein the remote control unit communicates with the processor via the wireless communication module.

7. A portable therapeutic fluid delivery device as in any of claims 1 to 6, further comprising a glucose sensing module for determining a glucose concentration of the user.

8. A portable therapeutic fluid delivery device as in any of claims 1 to 7, wherein the first therapeutic fluid is insulin, and the first dosing rate comprises a basal dosing component and/or a bolus component.

9. A portable therapeutic fluid delivery device as in any of claims 1 to 6 or 8, further comprising a sensing apparatus that measures at least one health related parameter of the user.

10. A portable therapeutic fluid delivery device as in claim 9, wherein the bolus component is determined based on data from the sensing apparatus.

11. A portable therapeutic fluid delivery device as in any of claims 9 or 10, wherein the sensing apparatus determines glucose concentration data and communicates the glucose concentration data to the processor, the processor controlling the first and/or the second dosing rate in response to the glucose concentration data.

12. A portable therapeutic fluid delivery device as in any of claims 1 to 11, wherein the second therapeutic fluid is an amylin analog.

13. A portable therapeutic fluid delivery device as in claim 12, wherein the amylin analog comprises pramlintide acetate.

14. A portable therapeutic fluid delivery device as in any of claims 1 to 11, wherein the second therapeutic fluid is a glucagon.

15. A portable therapeutic fluid delivery device as in any of claims 1 to 11, wherein the second therapeutic fluid is an exenatide.

16. A portable therapeutic fluid delivery device as in any of claims 12 to 15, wherein the first and/or second dosing rate is based on expected calorie and/or carbohydrate intake by the user.

17. A portable therapeutic fluid delivery device as in any of claims 1 to 16, further comprising at least one disposable part and a reusable part that mate with each other to form a dispensing patch unit, the at least one disposable part comprising the first reservoir and the second reservoir, and the reusable part comprising the processor and a pumping mechanism of at least one of the first and the second pumping mechanisms.

18. A device as in any of claims 1 to 17, further comprising:

at least one housing that contains the first reservoir, the second reservoir, the at least one pumping mechanism, and the processor; and

a cradle unit that comprises an attachment side for securing to the skin and a mating side that connects to the at least one housing.

19. A device as in any of claims 1 to 18, wherein the at least one pumping mechanism comprises a piston-type displacement pumping mechanism that comprises a propelling plunger.

20. A device as in any of claims 1 to 19, wherein the at least one pumping mechanism comprises a peristaltic pumping mechanism.

21. A device as in any of claims 1 to 20, wherein at least one of the first and the second reservoirs is collapsible such that it changes volume according to the volume of the therapeutic fluid contained therein.

22. A device as in any of claims 1 to 21, wherein the first reservoir is coupled to a first housing and the second reservoir is coupled to a second housing.

23. A device as in any of claims 1 to 21, wherein the first reservoir and the second reservoir are coupled to a single housing.

24. A device as in any of claims 1 to 23, further comprising one or more buttons via which the user can adjust the first and/or the second dosing rate.

25. A method for delivery of a therapeutic fluid to a user from a portable, ambulatory device, the method comprising:

delivering a first therapeutic fluid from a first reservoir of the device to the user via at least one cannula at a first dosing rate;

delivering a second therapeutic fluid from a second reservoir to the user via the at least one cannula at a second dosing rate; and

controlling the first dosing rate and the second dosing rate to affect a diabetes state of the user, the controlling being performed by a processor in the portable, ambulatory device.

26. A method as in claim 25, wherein the at least one cannula comprises a first cannula in fluid communication with the first reservoir and a second cannula in fluid communication with the second reservoir.

27. A method as in claim 25 wherein the first dosing rate is different from the second dosing rate.

28. A method as in claim 25, wherein the first therapeutic fluid is insulin, and the second therapeutic fluid is one of an amylin analog, a pramlintide acetate and an exenatide.

29. A method as in any of claims 25 to 28, wherein delivering the second therapeutic fluid is for prevention of post prandial hyperglycemia and/or user weight loss.

30. A method as in any of claims 25 to 29, further comprising communicating commands to the processor via a wireless remote control unit that comprises a user interface for entering commands and/or receiving data from the processor.

31. A method as in any of claims 25 to 30, wherein the first therapeutic fluid is insulin, and the first dosing rate comprises a first basal dosing component and/or a first bolus component.

32. A method as in any of claims 25 to 31, further comprising measuring at least one health related parameter of the user using a sensing apparatus in communication with the processor.

33. A method as in any of claims 31 or 32, wherein the first bolus component is determined based on data from the sensing apparatus.

34. A method as in any of claims 25 to 33, further comprising a glucose sensing module for determining a glucose concentration data of the user and for communicating the glucose concentration data to the processor, the processor controlling the first and/or the second dosing rate in response to the glucose concentration data.

35. A method as in any of claims 25 to 34, wherein the second therapeutic fluid is an amylin analog.

36. A method as in claim 35, wherein the first and/or second dosing rate is based on expected calorie and/or carbohydrate intake by the user.

37. A method as in any of claims 25 to 36, wherein the second therapeutic fluid is pramlintide, and wherein the dosage of the pramlintide is 10% of a total daily dose of insulin (TDD) before each meal.

38. A method as in any of claims 25 to 37, further comprising determining a tolerability of the user for the first and/or the second therapeutic fluid.

39. An infusion system for dispensing at least insulin and a second anti-diabetic agent into a user'"'"'s body, the system comprising:

a drug dispensing means that comprises a first reservoir and a first dispensing means for dispensing insulin for infusion into the user'"'"'s body and a second reservoir and a second dispensing means for dispensing the second anti-diabetic agent for infusion into the user'"'"'s body;

a sensing means that measures a glucose level; and

a processor that receives data regarding the glucose level from the sensing means and controls the drug dispensing means to regulate the dispensing of insulin and the anti-diabetic agent according to the glucose level.

40. An infusion system as in claim 39, wherein the system operates in a closed loop manner in which insulin delivery doses and/or anti-diabetic agent doses are adjusted according to the glucose level measured by the sensing means.

41. An infusion system as in any of claims 39 or 40, wherein the anti-diabetic agent is dispensed according to one or more characteristics of a meal to be consumed by the user.

42. An infusion system as in claim 41, wherein the anti-diabetic agent comprises one or more of an amylin analog, a pramlintide acetate and an exenatide.

43. An infusion system as in any of claims 39 to 42, further comprising the processor and a component that is adherable to the user'"'"'s skin, at least one of the first and the second reservoir, and at least one of the first and the second dispensing means.

44. An infusion system as in any of claims 39 to 43 wherein the first and the second dispensing means share a common cannula and/or one or more common pumping mechanism components.