SYSTEMS AND METHODS FOR DELIVERING DRUGS

• US 20090028824A1
• Filed: 07/28/2008
• Published: 01/29/2009
• Est. Priority Date: 07/26/2007
• Status: Active Grant

• Current Assignee: Massachusetts Institute of Technology
• Original Assignee: Entra Pharmaceuticals Inc.
• Inventors: Cima, Michael J., Chiang, Yet-Ming, Booma, Glenn R., Gyory, J. Richard
• Granted Patent: US 7,828,771 B2
• Time in Patent Office: Days
• US Class Current: 424/85.700
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/8231 using electrochemical gas generating device for the driving gas
• 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 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A patch pump device generally includes at least one fluid source, a fluid communicator, and an electrochemical actuator. The fluid communicator is in fluid communication with the fluid source. The electrochemical actuator is operative to cause fluid to be delivered from the fluid source into the fluid communicator.

Claims

1. A patch pump device comprising:

at least one fluid source;

a fluid communicator in fluid communication with the at least one fluid source; and

an electrochemical actuator operative to cause fluid to be delivered from the at least one fluid source into the fluid communicator.

2. The patch pump device of claim 1, wherein:

the electrochemical actuator comprises a charged electrochemical cell, and

at least a portion of the electrochemical cell experiences a change in volume or position in response to an applied current or voltage.

3. The patch pump device of claim 1, wherein:

the at least one fluid source comprises a deformable bladder, and

the electrochemical actuator is in direct contact with the deformable bladder.

4. The patch pump device of claim 1, further comprising a transfer structure positioned between the at least one fluid source and the electrochemical actuator, the transfer structure being adapted to transfer mechanical work produced by the electrochemical actuator to the at least one fluid source.

5. The patch pump device of claim 4, wherein:

the at least one fluid source comprises a chamber or barrel, and

the transfer structure comprises a piston.

6. The patch pump device of claim 1, further comprising control means operative to regulate fluid flow from the device.

7. The pump patch device of claim 1, further comprising control means operative to implement a release profile of fluid from the at least one fluid source that includes one or more of the following fluid flows:

a linear flow, a non-linear flow, a continuous flow, a discontinuous flow, a programmed flow, a user-initiated flow, and a feedback responsive flow.

8. The pump patch device of claim 1, further comprising control means operative to regulate fluid flow from the device in response to one or more sensed conditions.

9. The pump patch device of claim 8, wherein the sensed conditions comprise one of more of the following:

an actual current through the electrical circuit, an actual voltage across the electrical circuit, an actual discharge of the electrochemical actuator, an actual displacement of the electrochemical actuator, an actual fluid flow out of the fluid source, an actual fluid flow through the fluid communicator, an actual current rate through the electrical circuit, an actual voltage rate across the electrical circuit, an actual discharge rate of the electrochemical actuator, an actual displacement rate of the electrochemical actuator, an actual fluid flow rate out of the fluid source, and an actual fluid flow rate through the fluid communicator.

10. The pump patch device of claim 1, further comprising control means operative to regulate fluid flow from the device in response to one or more user inputs.

11. The pump patch device of claim 10, wherein the one or more user inputs comprise one or more of the following:

a request to initiate fluid flow, a request to discontinue fluid flow, a request to cause temporarily fluid flow, and a request to vary the fluid flow rate.

12. The patch pump device of claim 1, wherein:

the electrochemical actuator is positioned in an electrical circuit, and

the patch pump device further comprises control means operative to perform one or more of the following;

open the electrical circuit, close the electrical circuit, vary the current through the electrical circuit, and vary the resistance of the electrical circuit.

13. The patch pump device of claim 1, wherein:

the electrochemical actuator experiences a displacement that is relatively proportional to a current though an electrical circuit, and

a fluid flow rate out of the device is relatively proportional to a displacement rate of the electrochemical actuator.

14. The patch pump device of claim 13, further comprising control means operative to vary the displacement rate of the electrochemical actuator to vary the fluid flow rate out of the device.

15. The patch pump device of claim 1, further comprising a second fluid source.

16. The patch pump device of claim 15, wherein the fluid communicator is operative to be in fluid communication with the second fluid source and the electrochemical actuator is operative to cause fluid to be delivered from the second fluid source into the fluid communicator.

17. The patch pump device of claim 15, further comprising a second electrochemical actuator, wherein the fluid communicator is operative to be in fluid communication with the second fluid source and the second electrochemical actuator is operative to cause fluid to be delivered from the second fluid source into the fluid communicator.

18. The patch pump device of claim 16, wherein the at least one fluid source comprises a first drug, and the second fluid source comprises a second drug.

19. The patch pump device of claim 17, wherein the at least one fluid source comprises a first drug, and the second fluid source comprises a second drug.

20. The patch pump device of claim 19, which is operative to deliver the first and second drugs simultaneously.

21. The patch pump device of claim 19, which is operative to deliver the first and second drugs sequentially.

22. The patch pump device of claim 16, wherein the at least one fluid source comprises a drug, and the second fluid source comprises saline without a drug.

23. The patch pump device of claim 22, which is operative to deliver the drug intermittently and to deliver the saline without the drug at one or more times when the drug is not being delivered.

24. The patch pump device of claim 17, wherein the at least one fluid source comprises a drug, and the second fluid source comprises saline without a drug.

25. The patch pump device of claim 24, which is operative to deliver the drug intermittently and to deliver the saline without the drug at one or more times when the drug is not being delivered.

26. The patch pump device of claim 1, wherein the at least one fluid source comprises a fluid comprising at least one drug.

27. The patch pump device of claim 1, further comprising a drug storage reservoir comprising a drug, wherein the at least one fluid source is operative to be in fluid communication with the drug storage reservoir to reconstitute the drug in the fluid for delivery into the fluid communicator.

28. The patch pump device of claim 27, wherein the drug in the drug storage reservoir is in a lyophilized or other dry powder form.

29. A device comprising:

a fluid delivery system that includes;

at least one fluid source;

a fluid communicator in fluid communication with the at least one fluid source;

an electrochemical actuator operative to cause fluid to be delivered from the at least one fluid source into the fluid communicator; and

a housing suited for removably associating the fluid delivery system with the human body.

30. The device of claim 29, wherein:

the electrochemical actuator comprises a charged electrochemical cell, and

at least a portion of the electrochemical cell experiences a change in volume or position in response to an applied current.

31. The device of claim 29, wherein the at least one fluid source comprises a fluid drug formulation.

32. The device of claim 29, wherein the fluid communicator is inserted into the body via an insertion mechanism, the insertion mechanism being adapted for removable association with at least a portion of the housing.

33. The device of claim 29, wherein the housing comprises an adhesive for removably associating the device with the human body.

34. The device of claim 29, wherein:

the housing comprises a base portion and a movable portion, and

the housing can be moved between an unassembled position and an assembled position by moving the movable portion with reference to the base portion.

35. The device of claim 34, wherein when the housing is in the assembled position, the housing takes on an outer shape that is relatively smooth and free from sharp edges.

36. The device of claim 34, wherein when the housing is in the assembled position, the base portion and the movable portion releasably lock together.

37. The device of claim 34, wherein the fluid delivery system is activated and deactivated by moving the housing between the assembled position and the assembled position.

38. The device of claim 34, wherein:

the base portion comprises a first electrical contact,

the movable portion comprises a second electrical contact, and

the first and second electrical contacts are positioned to contact each other when the housing is in the assembled position but not when the housing is in the unassembled position.

39. The device of claim 34, wherein the fluid communicator is associated with the housing such that the fluid communicator is retracted inside the housing when the housing is in the unassembled position and the fluid communicator is transferred outside of the housing when the housing is in the assembled position.

40. The device of claim 34, wherein the fluid communicator is inserted by moving the housing from the unassembled position to the assembled position.

41. The device of claim 29, further comprising a control system operative to regulate fluid flow from the device.

42. The device of claim 41, further comprising a feedback system in communication with the control system.

43. The device of claim 41, further comprising a user interface in communication with the control system.

44. A method for administering a drug to a patient in need thereof, the method comprising:

securing a disposable infusion pump to the patient'"'"'s skin, wherein the disposable infusion pump comprises (i) a reservoir storing a fluid which comprises at least one drug, (ii) an electrochemical actuator; and

(iii) at least one fluid communicator positioned or positionable to penetrate the patient'"'"'s skin; and

actuating the electrochemical actuator to cause the fluid to be delivered from the reservoir through the fluid communicator, and into the patient.

45. The method of claim 44, wherein the drug is selected from the group consisting of insulin, leutenizing hormone releasing hormone, follicle stimulating hormone, immunoglobulin, apomorphine, interferon A, octreotide, ketamine, heparin, corticosteroids, opioids, non-opioid analgesics;

tizanidine, and combinations thereof.

46. A method for treating refractory depression in a patient, comprising:

administering ketamine to the patient via continuous infusion using a disposable infusion pump.

47. A method for treating hepatitis C in a patient, comprising:

administering Interferon A to the patient via continuous infusion using a disposable infusion pump.

48. A method for treating Parkinson'"'"'s Disease in a patient, comprising:

administering apomorphine or other dopamine agonists to the patient via continuous infusion using a disposable infusion pump.

49. The method of claim 48, wherein the disposable infusion pump is operative to deliver an adjustable baseline and/or a bolus of the apomorphine or other dopamine agonists for treating an “

off”

state in the patient.

50. A method for treating pain in a patient, comprising:

administering fentanyl to the patient via continuous infusion using a disposable infusion pump.

51. A method for subcutaneously administering a sustained release depot formulation into a patient, comprising:

administering the depot formulation to the patient via continuous infusion using a disposable infusion pump.

52. The method of claim 51, wherein the depot formulation is delivered at a rate of less than 3 mL per hour over a duration of at least one hour.

53. The method of claim 51, wherein the depot formulation is delivered at a rate of less than 1 mL per hour over a duration of at least one hour.