Apparatus and methods for repetitive microjet durg delivery priority statement

• US 20040260234A1
• Filed: 04/21/2004
• Published: 12/23/2004
• Est. Priority Date: 04/21/2003
• Status: Abandoned Application

• Current Assignee: Corium International, Inc.
• Original Assignee: Corium International, Inc.
• Inventors: Srinivasan, Ravi, Rathnasingham, Ruben, Arkilic, Errol Bernard
• Application Number:
  US10/829,888
• Publication Number:
  US 20040260234A1
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/025 Bubble jet droplet ejection devices
• CPC Class Codes: A61M 2005/3022 Worn on the body, e.g. as patches pressure infusion of the skin patch type A61M5/14248
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/204 connected to external reservoirs for multiple refilling
• CPC Class Codes: A61M 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

An active, transdermal delivery system includes a support structure and a fluid reservoir within the support structure configured to contain a fluid to be delivered transdermally. There is also at least one exit orifice defined in the support structure that is in communication with the fluid reservoir. The orifice has a diameter of between about 1 μm and 500 μm. Furthermore, a repeatable activation means is disposed within the support structure and is in cooperation with the exit orifice for ejection of fluid in response to an activation signal.

Claims

1. An active, fluid delivery system, comprising:

a support structure;

at least one exit orifice defined in the support structure, said orifice having a diameter between about 1 μ

m and about 500 μ

m;

a fluid reservoir configured to contain a fluid to be delivered to a tissue and communicating with said at least one exit orifice; and

repeatable activation means cooperating with said fluid reservoir and said at least one exit orifice for ejection of fluid in response to an activation signal.

2. The delivery system of claim 1, wherein said fluid reservoir and said repeatable activation means are disposed in the support structure.

3. The delivery system of claim 1, wherein said support structure is adapted to be in contact with a skin surface with the at least one exit orifice adjacent the skin surface.

4. The delivery system of claim 1, wherein the support structure includes a nozzle defining said orifice, said nozzle being configured and dimensioned to accelerate the fluid exiting therefrom.

5. The delivery system of claim 1, further comprising a controller in communication with the repeatable activation means, the controller being capable of generating the activation signal.

6. The delivery system of claim 5, wherein said controller is a microprocessor programmable to control a patterned administration regime.

7. The delivery system of claim 6, wherein the sustained administration regime occurs over a time period of not less than about 500 ms and not more than about 10 days.

8. The delivery system of claim 4, wherein, prior to ejection, the nozzle is configured to maintain the fluid remote from the tissue a substantially fixed distance.

9. The delivery system of claim 8, wherein the fixed distance spaces the fluid, prior to ejection of the fluid, not more than about 5000 μ

m from the tissue.

10. The delivery system of claim 1, further comprising an array of exit orifices defined in the support structure and in communication with the fluid reservoir.

11. The delivery system of claim 1, wherein the fluid reservoir includes a storage reservoir configured to store fluid.

12. The delivery system of claim 11, further comprising a pressurization mechanism for pressurizing the stored fluid in the storage reservoir.

13. The delivery system of claim 11, wherein the storage reservoir is divided into multiple storage reservoirs by a reservoir divider.

14. The delivery system of claim 13, further comprising an array of exit orifices defined in the support structure, wherein a first exit orifice is in communication with a first storage reservoir storing a first fluid such that the first fluid can be ejected through the first exit orifice and at least a second exit orifice is in communication with at least a second storage reservoir storing a second fluid such that the second fluid can be ejected through the second exit orifice.

15. The delivery system of claim 13, further comprising a reservoir divider disruption mechanism configured and dimensioned to disrupt the reservoir divider prior to administration of a substance contained in the reservoir.

16. The delivery system of claim 15, wherein said reservoir divider disruption mechanism is a piezoelectric mechanism.

17. The delivery system of claim 1, further comprising:

a sensor for sensing if a condition is satisfied; and

a control unit configured to produce the activation signal to actuate the repeatable activation means upon receiving a signal from the sensor that the condition is satisfied.

18. The delivery system of claim 1, further comprising:

a control unit configured to produce the activation signal to actuate the repeatable activation means; and

a sensor for sensing if a condition is satisfied and, if so, communicating a signal to the control unit to not produce the activation signal, thereby, not actuating the repeatable activation means.

19. The delivery system of claim 17, wherein the sensor is located remotely from the support structure.

20. The delivery system of claim 17, wherein the sensor is implanted into a patient.

21. The delivery system of claim 17, wherein the sensor is capable of sensing a biological condition of a patient.

22. The delivery system of claim 17, wherein said sensor is coupled with said support structure such that said sensor determines conditions related to administration.

23. The delivery system of claim 22, wherein said sensor is a temperature sensor for determining if said support structure is positioned adjacent the tissue.

24. The delivery system of claim 22, wherein said sensor is a pressure sensor for providing a feed-back mechanism for monitoring functionality of the repeatable activation means.

25. The delivery system of claim 1, further comprising an antagonist reservoir configured and dimensioned in communication with the fluid reservoir, integrity of both reservoirs being in cooperation such that upon compromise of the fluid reservoir'"'"'s integrity, the integrity of the antagonist reservoir is compromised, thereby releasing an antagonist component from the antagonist reservoir capable of inactivating the fluid.

26. The delivery system of claim 1, further comprising a power supply for supplying a drive force for the activation signal and a drive force for the repeatable activation means.

27. The delivery system of claim 1, wherein the repeatable activation means is a piezoelectric mechanism that generates a pressure change in the fluid.

28. The delivery system of claim 1, wherein the repeatable activation means is a phase change mechanism that generates a pressure change in the fluid.

29. The delivery system of claim 1, wherein said repeatable activation means is an electromagnetic mechanism that generates a pressure change in the fluid.

30. The delivery system of claim 1, wherein said repeatable activation means is a high pressure hydraulic mechanism that generates a pressure change in the fluid.

31. The delivery system of claim 1, wherein said repeatable activation means includes multiple explosive mechanisms, each explosive mechanism capable of generating a pressure change in the fluid upon detonation of said explosive mechanism.

32. The delivery system of claim 1, further comprising a user interface in communication with said repeatable activation means, said user interface being configured to initiate the activation signal in response to manipulation of said user interface.

33. The delivery system of claim 1, wherein the fluid is to be delivered transdermally across epithelial tissue.

34. The delivery system of claim 1, wherein said repeatable activation means generates a pulse width of not less than about 5 ns and not more than about 10 μ

s.

35. The delivery system of claim 1, wherein a frequency of the repeatable activation means and a duty cycle and length of ejection of fluid are controlled by a control unit.

36. The delivery system of claim 1, further comprising a memory for storing a delivery profile and delivery history of the fluid delivered to the tissue.

37. The delivery system of claim 1, wherein the fluid includes an analyte for delivery to the tissue and subsequent diagnoses of a biological condition.

38. An active, fluid delivery system, comprising:

a support structure;

a fluid ejection chamber within the support structure;

at least one exit orifice defined in the support structure and communicating with the fluid ejection chamber; and

activation means disposed in the fluid ejection chamber,

wherein said fluid ejection chamber, at least one exit orifice, and activation means are configured and dimensioned together for continuously cyclic repeatable ejection of fluid in the range of about 1 pl to about 800 nl.

39. The delivery system of claim 38, wherein said support structure is adapted to be in contact with a skin surface with the at least one exit orifice adjacent the skin surface.

40. The delivery system of claim 38, wherein the support structure includes a nozzle in communication with the fluid ejection chamber and the nozzle has an exit orifice configured and dimensioned to accelerate the fluid exiting therefrom.

41. The delivery system of claim 38, further comprising a controller in communication with the activation means for delivering an activation signal to the activation means.

42. The delivery system of claim 40, wherein, prior to ejection, the nozzle is configured to maintain the fluid remote from a biological tissue a substantially fixed distance.

43. The delivery system of claim 38, further comprising:

a control unit configured to produce an activation signal to actuate the activation means; and

a sensor for sensing if a condition is satisfied and, if so, communicating a signal to the control unit to produce the activation signal and actuate the activation means.

44. An active, fluid delivery system, comprising:

a support structure;

a fluid ejection chamber within the support structure configured to contain a fluid to be delivered;

at least one exit orifice defined in the support structure and communicating with the fluid ejection chamber;

activation means disposed in the fluid ejection chamber; and

a controller programmed to activate the activation means to deliver a sustained repetitive administration regime from not less than about 500 ms to not more than about 10 days.

45. The delivery system of claim 44, wherein said support structure is adapted to be positioned adjacent a biological tissue with the at least one exit orifice adjacent the biological tissue.

46. The delivery system of claim 44, wherein the support structure includes a nozzle in communication with the fluid ejection chamber, the nozzle having an exit orifice configured and dimensioned to accelerate the fluid exiting therefrom, and wherein the nozzle is configured to maintain the fluid remote from a biological tissue a substantially fixed distance prior to ejection.

47. The delivery system of claim 44, further comprising an antagonist reservoir configured and dimensioned in association with the fluid ejection chamber such that prior to the fluid ejection chamber rupturing, the antagonist reservoir ruptures and releases an antagonist component into the fluid to inactivate the fluid.

48. An active, fluid delivery system, comprising:

a support structure;

a fluid reservoir within the support structure configured to contain a fluid to be delivered;

at least one exit orifice defined in the support structure and communicating with the fluid reservoir; and

a piezoelectric mechanism that mechanically deform upon application of a voltage, the piezoelectric mechanism being disposed within the support structure in cooperation with the at least one exit orifice for ejection of fluid in response to an activation signal.

49. An active, transdermal delivery system, comprising:

a support structure;

a fluid reservoir within the support structure configured to contain a fluid to be delivered;

at least one exit orifice defined in the support structure and communicating with the fluid reservoir; and

a phase change mechanism that vaporizes an actuation fluid in response to an activation signal, thereby generating a pressure change in the fluid and ejecting fluid from the exit orifice.

50. An active, transdermal delivery system, comprising:

a support structure;

a fluid reservoir within the support structure configured to contain a fluid to be delivered;

at least one exit orifice defined in the support structure and in communication with the fluid reservoir; and

a phase change mechanism that vaporizes at least some of the fluid in response to an activation signal, thereby generating a pressure change in the fluid and ejecting a portion of the fluid from the exit orifice.

51. The delivery system of claim 50, further comprising a flexible membrane dividing the fluid reservoir into a first compartment and a second compartment, wherein said first compartment contains an actuation fluid and said second compartment contains the fluid to be delivered.

52. The delivery system of claim 50, further comprising an actuation fluid positioned near said phase change mechanism, the actuation fluid being immiscible with the fluid to be delivered.

53. An active, transdermal delivery system, comprising:

a support structure;

a fluid reservoir within the support structure configured to contain a fluid to be delivered;

at least one exit orifice defined in the support structure and communicating with the fluid reservoir; and

an electromagnetic mechanism disposed within the fluid reservoir in cooperation with the at least one exit orifice for ejection fluid in response to an activation signal.

54. An active, transdermal delivery system, comprising:

a support structure;

a fluid reservoir within the support structure configured to contain a fluid to be delivered;

at least one exit orifice defined in the support structure and communicating with the fluid reservoir; and

a high pressure hydraulic mechanism disposed within the support structure in cooperation with the at least one exit orifice for ejection of fluid in response to an activation signal.

55. An active, fluid delivery system having a support structure configured and dimensioned with an array of administration chambers, wherein each administration chamber comprises:

a exit orifice defined in the support structure, said exit orifice having a diameter between about 1 μ

m and about 500 μ

m;

a fluid reservoir configured to contain a fluid to be delivered to a tissue, wherein said fluid reservoir is in communication with said exit orifice; and

a repeatable activation means cooperating with said fluid reservoir and said exit orifice for ejection of fluid in response to an activation signal.

56. A method for active, transdermal delivery, comprising:

positioning a support structure defining an orifice adjacent a biological tissue, said orifice having a diameter of between about 1 μ

m and about 500 μ

m, and said support structure in fluid communication with a fluid to be administered to the biological tissue; and

actively and repetitively ejecting fluid into the biological tissue.

57. The method of claim 56, further comprising, before said positioning, programming a controller with a sustained administration regime according to a substance to be delivered and a patients needs.

58. The method of claim 56, further comprising, during active and repetitive ejection of said fluid, recording administration data and associated patient data throughout an administration regime.

59. The method of claim 58, further comprising interfacing with the controller to retrieve the administration data during the administration regime.

60. The method of claim 57, further comprising interfacing with the controller to change the administration regime.

61. The method of claim 56, wherein said fluid includes an analyte for performing a diagnosis on a biological system of said biological tissue.

62. The method of claim 56, further comprising, after actively and repetitively ejecting the fluid, extracting fluid from said biological tissue for analysis.

63. The method of claim 56, wherein said actively and repetitively ejecting fluid into the biological tissue is configure to disrupt a stratum corneum of an epithelial tissue such that biological fluid below the stratum corneum can be removed from said biological tissue.