Systems and methods for delivering drugs

• US 7,828,771 B2
• Filed: 07/28/2008
• Issued: 11/09/2010
• Est. Priority Date: 07/26/2007
• Status: Expired due to Fees

• Current Assignee: Massachusetts Institute of Technology
• Original Assignee: Entra Pharmaceuticals Inc.
• Inventors: Cima, Michael J., Chiang, Yet-Ming, Booma, Glenn R., Gyory, J. Richard
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/181,085
• Publication Number:
  US 20090028824A1
• Time in Patent Office: 834 Days
• Field of Search: 604/67, 604/132, 604/133, 604/151, 417/87.5
• US Class Current: 604/132
• 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;

an insertion mechanism configured to insert the fluid communicator into the body of a patient, the insertion mechanism including a spring coupled to the fluid communicator, and a latch configured to restrain the spring in a compressed state; and

an electrochemical actuator including an electrode configured to deflect as the electrochemical actuator discharges, the deflection of the electrode being 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 at least one fluid source comprises a deformable bladder, and

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

3. 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.

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

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

the transfer structure comprises a piston.

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

6. 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.

7. 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.

8. The pump patch device of claim 7, wherein the sensed conditions comprise one or more of the following:

a current applied through the electrochemical actuator, a voltage applied across the electrochemical actuator, the discharge of the electrochemical actuator, a displacement of the electrochemical actuator, a fluid flow out of the fluid source, a fluid flow through the fluid communicator, a current rate applied through the electrochemical actuator, a voltage rate applied across the electrochemical actuator, a discharge rate of the electrochemical actuator, a displacement rate of the electrochemical actuator, a fluid flow rate out of the fluid source, and a fluid flow rate through the fluid communicator.

9. 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.

10. The pump patch device of claim 9, 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 temporary fluid flow, and a request to vary the fluid flow rate.

11. 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.

12. 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.

13. The patch pump device of claim 12, further comprising control means operative to vary the displacement rate of the electrochemical actuator to vary the fluid flow rate out of the device.

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

15. The patch pump device of claim 14, 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.

16. The patch pump device of claim 14, 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.

17. The patch pump device of claim 15, wherein the at least one fluid source comprises a first drug, and the second fluid source comprises a second drug.

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 18, which is operative to deliver the first and second drugs simultaneously.

20. The patch pump device of claim 18, which is operative to deliver the first and second drugs sequentially.

21. The patch pump device of claim 15, wherein the at least one fluid source comprises a drug, and the second fluid source comprises saline without a drug.

22. The patch pump device of claim 21, 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.

23. 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.

24. The patch pump device of claim 23, 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.

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

26. 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.

27. The patch pump device of claim 26, wherein the drug in the drug storage reservoir is in a lyophilized or other dry powder form.

42. The patch pump device of claim 1, wherein the fluid source includes a drug 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.

44. The patch pump device of claim 1, wherein the spring transitions from the compressed state to an uncompressed state when the latch is released, thereby inserting the fluid communicator into the body of a patient.

45. The patch pump device of claim 1, wherein the insertion mechanism includes a needle slidably disposed within the fluid communicator.

28. A device for delivering fluid to the body of a patient, comprising:

at least one fluid source;

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

a housing suited for removably associating the fluid source and the cannula with the body of the patient, the housing including a base portion and a movable portion and being movable between an unassembled position and an assembled position by moving the movable portion with reference to the base portion;

an insertion mechanism, the insertion mechanism operable to cause the cannula to move with respect to the housing and to insert the cannula into the body of the patient; and

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

29. The device of claim 28, 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.

30. The device of claim 28, wherein the at least one fluid source comprises a fluid drug formulation.

31. The device of claim 28, wherein the insertion mechanism is adapted for removable association with at least a portion of the housing.

32. The device of claim 28, wherein the housing comprises an adhesive for removably associating the device with the human body.

33. The device of claim 28, 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.

34. The device of claim 28, wherein when the housing is in the assembled position, the base portion and the movable portion releasably lock together.

35. The device of claim 28, wherein the electrochemical actuator is activated by moving the housing between the unassembled position and the assembled position.

36. The device of claim 28, wherein:

the base portion comprises a first electrical contact,

the movable portion comprises a second electrical contact, and

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

37. The device of claim 28, wherein the cannula is associated with the housing such that the cannula is retracted inside the housing when the housing is in the unassembled position and the cannula is transferred outside of the housing when the housing is in the assembled position.

38. The device of claim 28, wherein the cannula is inserted by moving the housing from the unassembled position to the assembled position.

39. The device of claim 28, further comprising a control system operative to regulate fluid flow from the device.

40. The device of claim 39, further comprising a feedback system in communication with the control system.

41. The device of claim 39, further comprising a user interface in communication with the control system.

43. The device of claim 30, wherein the a fluid drug formulation includes a drug 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. The device of claim 28, wherein the electrochemical actuator includes an electrode configured to deflect as the electrochemical actuator discharges thereby causing fluid to be delivered from the at least one fluid source into the cannula.

47. The device of claim 28, wherein the insertion mechanism includes a spring coupled to the cannula, and a latch configured to restrain the spring in a compressed state.

48. The device of claim 47, wherein the spring transitions from the compressed state to an uncompressed state when the latch is released, thereby inserting the cannula into the body of a patient.

49. A device for delivering fluid to the body of a patient, comprising:

a fluid delivery system including a fluid source, a cannula, and an electrochemical actuator having a bimorph electrode and configured to change volume or position as the bimorph electrode discharges; and

a housing configured for removably associating the fluid delivery system with the body of the patient, the housing being movable between an unassembled configuration in which the fluid delivery system is in a deactivated state, and an assembled configuration in which a first portion forms a cooperative fit with a second portion, the first portion of the housing includes a first electrical contact and the second portion of the housing includes a second electrical contact, the first and second electrical contacts being positioned to contact each other when the housing is in the assembled position to activate the electrochemical actuator thereby delivering fluid from the fluid source through the cannula.

50. The device of claim 49, wherein the cannula is in fluidically isolated from the fluid source in the unassembled configuration.

51. The device of claim 49, wherein the cannula is movable from a retracted position in which the cannula is disposed inside the housing when the housing is in the unassembled configuration and a deployed position in which the cannula protrudes outside the housing when the housing is in the assembled configuration.

52. The device of claim 49, further comprising:

an insertion mechanism, the insertion mechanism configured to insert the cannula into the body of the patient when the housing is moved between an unassembled configuration and the assembled configuration.