Drug delivery device

• US 9,061,097 B2
• Filed: 06/07/2011
• Issued: 06/23/2015
• Est. Priority Date: 06/07/2010
• Status: Active Grant

• Current Assignee: Amgen Inc.
• Original Assignee: Amgen Inc.
• Inventors: Holt, Mark D., Cairns, Alexander S., Romacker, Mathias
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US13/155,017
• Publication Number:
  US 20120010594A1
• Time in Patent Office: 1,477 Days
• Field of Search: 604/890.1, 604/131, 604134-148
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/1583 Needle extractors
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/1486 the bags being substantially completely surrounded by fluid
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user

Abstract

A drug delivery device includes a housing having an interior space, a needle having retracted and deployed states, an injector to move the needle between retracted and deployed states, and a reservoir disposed within the interior space, the reservoir configured to receive a volume of a drug and to be in fluid communication with the needle. The drug delivery device also includes a controller coupled to the injector and the reservoir, and configured to actuate the injector to move the needle from the retracted state to the deployed state only once, and to actuate the reservoir to deliver the volume of the drug to the patient as a single bolus after a preselected time period has elapsed, the controller disposed within the interior space and configured prior to being disposed within the interior space. The delivery device is wearable, disposable, and single-use.

Claims

1. A drug delivery device comprising:

a disposable housing having an interior surface defining an interior space, and an exterior surface;

a needle having a retracted state wherein the needle is withdrawn inside of the interior space and a deployed state wherein a pointed end of the needle projects beyond the exterior surface of the housing;

an injector coupled to the needle to move the needle between the retracted and deployed states;

a reservoir disposed within the interior space, the reservoir configured to receive a volume of a drug and to be in fluid communication with the needle; and

a controller coupled to the injector and the reservoir, the controller being configured to actuate the injector to move the needle from the retracted state to the deployed state only once, to only once determine when a preselected time period has elapsed after initiation of action of the controller, and to actuate the reservoir to deliver the volume of the drug to the patient as a single bolus after the preselected time period has elapsed after the initiation of the action of the controller, the controller disposed within the interior space and configured prior to being disposed within the interior space,

wherein the delivery device is wearable, disposable, and single-use.

2. The delivery device according to claim 1, further comprising a volume of an erythropoiesis stimulating agent disposed in the reservoir.

3. The delivery device according to claim 1, further comprising a volume of a granulocyte colony-stimulating factor disposed in the reservoir.

4. The delivery device according to claim 1, further comprising a volume of a TNF blocker disposed in the reservoir.

5. The delivery device according to claim 1, further comprising a volume of a pegylated granulocyte colony-stimulating factor disposed in the reservoir.

6. The delivery device according to claim 1, further comprising a volume of interleukin-receptor specific antibody disposed in the reservoir.

7. The delivery device according to claim 1, further comprising a volume of IGF-receptor specific antibody disposed in the reservoir.

8. The delivery device according to claim 1, further comprising a volume of TGF-specific antibody disposed in the reservoir.

9. The delivery device according to claim 1, wherein the controller determines that the preselected time period has elapsed.

10. The delivery device according to claim 9, wherein the controller determines that at least a 24-hour period has elapsed after actuation of an input device.

11. The delivery device according to claim 1, wherein the controller is configured to actuate the reservoir to deliver the volume of the drug to the patient as a single bolus in less than thirty minutes.

12. The delivery device according to claim 11, wherein the controller is configured to actuate the reservoir to deliver the volume of the drug to the patient as a single bolus in less than six seconds.

13. The delivery device according to claim 1, wherein the controller is configured to actuate the injector to move the needle from the deployed state to the retracted state only once.

14. The delivery device according to claim 1, comprising an input device coupled to the controller, the controller responsive to actuation of the input device to initiate action of the controller.

15. The delivery device according to claim 1, wherein the controller comprises a microprocessor programmed to actuate the injector and to actuate the reservoir.

16. The delivery device according to claim 1, further comprising a pump, wherein the controller actuates the pump to move the volume of drug from the reservoir to the needle.

17. The delivery device according to claim 16, further comprising a pinch valve disposed between the pump and the needle, wherein the controller opens the pinch valve prior to actuating the pump.

18. The delivery device according to claim 1, wherein the interior space is a sealed space.

19. The delivery device according to claim 1, further comprising an adhesive adapted to releasably secure the housing to skin during a single application, the adhesive disposed on a portion of the exterior surface and covered with a removable, disposable sheet prior to application of the housing to the skin of a patient.

20. The delivery device according to claim 1, comprising a fill port in fluid communication with the reservoir, the fill port having an inlet disposed on the exterior surface of the housing.

21. A kit comprising a delivery device according to claim 1, in combination with a syringe.

22. The delivery device according to claim 10, wherein the at least 24-hour period is 25, 26, 27, 28 or 29 hours or a fraction thereof.

23. The delivery device according to claim 22, wherein the at least 24-hour period is 27 hours or a fraction thereof.

24. The delivery device according to claim 9, wherein the controller determines that 22 or 23 hours has elapsed.

25. The drug delivery device of claim 1, comprising a catheter or soft cannula surrounding the needle and movable together with the needle.

26. The drug delivery device of claim 1, the controller being configured to actuate the injector to move the needle from the retracted state to the deployed state upon initiation of the action of the controller such that the preselected time period begins when the injector is actuated to move the needle from the retracted state to the deployed state.

27. A method of operation of a wearable, disposable, single-use drug delivery device, the method comprising:

initiating a controller contained within an interior space defined by a housing of the delivery device;

automatically injecting a pointed end of a needle from the interior space into the patient to define an injection site only once according to the controller;

determining, only once with the controller, when a preselected time period has elapsed after initiation of the controller; and

automatically actuating a reservoir to deliver a volume of a drug to the patient through the injection site as a single bolus after the preselected time period has been determined to have elapsed according to the controller.

28. The method according to claim 27, wherein the drug comprises an erythropoiesis stimulating agent.

29. The method according to claim 27, wherein the drug comprises a granulocyte colony-stimulating factor.

30. The method according to claim 27, wherein the drug comprises a TNF blocker.

31. The method according to claim 27, wherein the drug comprises a pegylated granulocyte colony-stimulating factor.

32. The method according to claim 27, wherein the drug comprises interleukin-receptor specific antibody.

33. The method according to claim 27, wherein the drug comprises IGF-receptor specific antibody.

34. The method according to claim 27, wherein the drug comprises TGF-specific antibody.

35. The method according to claim 27, further comprising automatically determining that the preselected time period has elapsed according to the controller contained within the interior space, the controller being configured to determine the preselected time period before the controller is disposed in the interior space.

36. The method according to claim 35, wherein the preselected time period is at least a 24-hour period.

37. The method according to claim 27, comprising automatically retracting the pointed end of the needle into the interior space only once according to the configuration of the controller contained within the interior space.

38. The method of claim 27, comprising inserting a catheter or soft cannula into subcutaneous tissue of the patient with the needle.

39. The method according to claim 27, wherein automatically injecting the pointed end of a needle comprises automatically injecting the needle with an injector configured to move the needle, the injector being enclosed entirely within the interior space defined by the housing and fixed relative to the housing.

40. The method of claim 27, comprising automatically injecting the pointed end of the needle into the patient upon initiation of the controller such that the preselected time period begins when the pointed end of the needle is injected into the patient.

41. A wearable, single-use drug delivery device comprising:

a disposable housing having an interior surface and an exterior surface, the interior surface defining an interior space;

a needle movable between a retracted position where the needle is withdrawn inside of the interior space of the housing and a deployed position where a pointed end of the needle projects from the exterior surface of the housing;

a catheter or soft cannula surrounding the needle;

an injector enclosed within the interior space of the housing and configured to move the needle between the retracted position and the deployed position;

a reservoir enclosed within the interior space of the housing and in fluid communication with the needle, the reservoir being configured to receive a volume of a drug; and

a controller operatively connected to the injector and the reservoir, the controller being configured to only once;

(i) actuate the injector to move the needle from the retracted position to the deployed position, (ii) insert the catheter or soft cannula into subcutaneous tissue of a patient, (iii) move the needle from the deployed position to the retracted position, (iv) determine when a preselected time period has elapsed after actuation of the injector to move the needle from the retracted position to the deployed position, and (v) actuate the reservoir to deliver the volume of the drug to the patient via the needle as a single bolus.

42. The wearable, single-use drug delivery device of claim 41, the injector being fixed relative to the housing.