TRANSDERMAL PATCH SYSTEM

• US 20090259176A1
• Filed: 04/09/2008
• Published: 10/15/2009
• Est. Priority Date: 04/09/2008
• Status: Abandoned Application

• Current Assignee: Los Gatos Research (ABB Limited)
• Original Assignee: Los Gatos Research (ABB Limited)
• Inventors: YAIRI, Micah B.
• Application Number:
  US12/100,250
• Publication Number:
  US 20090259176A1
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 35/10 Wearable devices, e.g. garments, glasses or masks
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/141 with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

A transdermal patch system configured as a patch or pump assembly may be placed into contact upon a skin surface to transport drugs or agents transdermally via any number of different mechanisms such as microporous membranes, microneedles, in-dwelling catheters, etc. The assembly may enclose or accommodate a reservoir configured as an elongate microchannel to contain the drug or agent suspended in a fluid vehicle. The reservoir may also be fluidly coupled via microchannels to transport the drugs into or against an underlying skin surface as driven or urged via a pump and controlled by an electronic control circuitry which may be programmed to affect any number of treatment regimens.

Claims

1. A system for transdermal drug delivery, comprising:

a housing configured for placement upon a skin surface,

a drug delivery mechanism within or along the housing positioned to contact the skin surface; and

a reservoir contained within or along the housing and fluidly coupled to the drug delivery mechanism, wherein the reservoir comprises an elongate microchannel extending within or along the housing.

2. The system of claim 1 wherein the housing is comprised of two or more separate sections which are securely attached to one another.

3. The system of claim 1 further comprising a pump in fluid communication with the reservoir and the drug delivery mechanism.

4. The system of claim 3 wherein the pump is further coupled to an opening through which air is introduced.

5. The system of claim 3 further comprising an electronic control circuitry within or along the housing and in electrical communication with the pump.

6. The system of claim 5 wherein the electronic control circuitry is configured to control actuation and/or pumping rates of the pump according to a programmable dosage profile.

7. The system of claim 6 wherein the electronic control circuitry comprises an on-chip clock configured to track a time and/or date of the programmable dosage profile.

8. The system of claim 5 wherein the electronic control circuitry comprises a user-activated control for actuating the pump and/or dosage for a predetermined period of time.

9. The system of claim 5 further comprising a controller separate from the electronic control assembly and in wireless communication therewith.

10. The system of claim 5 wherein the electronic control circuitry further comprises an RFID assembly configured to wirelessly communicate with the pump.

11. The system of claim 3 wherein the pump comprises a linear actuator having a piston head coupled thereto and which is movable within the reservoir.

12. The system of claim 11 further comprising a positioning sensor assembly configured to sense a position of the piston head relative to the reservoir such that a differential volume of the reservoir is determined.

13. The system of claim 12 wherein the positioning sensor assembly comprises a capacitive film contacting the piston head and in electrical communication with one or more sensors positioned along the reservoir.

14. The system of claim 11 further comprising a piezoelectric transducer vibrationally coupled to the piston head such that actuation of the transducer forces the piston head to rotate and/or translate in an axial direction.

15. The system of claim 1 wherein the drug delivery mechanism comprises a microporous membrane having an area configured for contacting the skin surface.

16. The system of claim 1 wherein the drug delivery mechanism comprises a microneedle array projecting from the housing and having a length sized to pierce the skin surface.

17. The system of claim 16 further comprising an adhesive layer beneath and/or adjacent to the microneedle array whereby contact of the layer upon the skin surface immobilizes an underlying portion of the skin surface relative to the microneedle array extending into the portion of the skin surface.

18. The system of claim 17 wherein the adhesive layer is localized upon the skin surface directly about the microneedle array such that a remainder of the skin surface is unrestricted relative to the housing.

19. The system of claim 18 further comprising a second adhesive layer separated from the adhesive layer and which contacts the remainder of the skin surface and immobilizes the remainder relative to the housing.

20. The system of claim 1 further comprising a lid assembly which fluidly seals the reservoir, wherein the lid assembly further comprises a gas-permeable membrane which allows for gas infusion into the reservoir while maintaining a fluid seal.

21. The system of claim 1 wherein the microchannel reservoir has a cross-sectional dimension ranging from 1 micron to 1000 microns.

22. The system of claim 21 wherein the microchannel reservoir has a length ranging from 1 millimeter to 1 meter.

23. The system of claim 1 wherein the microchannel reservoir extends within or along the housing in an alternating back-and-forth pattern over the width and/or length of the housing.

24. The system of claim 1 wherein the microchannel reservoir extends within or along the housing in a spiral pattern.

25. The system of claim 1 wherein the microchannel reservoir has one or more separate channels aligned parallel to one another, wherein each of the one or more separate channels converge into a single microchannel fluidly coupled to the drug delivery mechanism.

26. The system of claim 1 wherein the elongate microchannel is aligned within a first plane along the housing and further comprising at least a second microchannel aligned within a second plane along the housing which is adjacent to the first plane.

27. The system of claim 1 further comprising a second microchannel reservoir separate from the elongate microchannel.

28. The system of claim 27 wherein the elongate microchannel contains a first drug and the second microchannel reservoir contains a second drug different from the first drug.

29. The system of claim 1 wherein the reservoir resides in a package or cartridge removably secured to the housing.

30. A method of delivering one or more drugs transdermally, comprising:

positioning a housing upon or in proximity to a skin surface;

pumping one or more drugs to a drug delivery mechanism placed onto or through a skin surface underlying the housing, and

wherein the one or more drugs are contained within an elongate microchannel reservoir located within or along the housing.

31. The method of claim 30 wherein positioning a housing comprises securing the housing to the skin surface via an adhesive or strap.

32. The method of claim 30 wherein pumping comprises placing a microporous membrane into contact against the skin surface.

33. The method of claim 30 wherein pumping comprises inserting a microneedle array into the skin surface.

34. The method of claim 33 further comprising immobilizing the skin surface relative to the microneedle array extending into the skin surface.

35. The method of claim 34 wherein immobilizing comprises locally immobilizing the skin surface directly about the microneedle array via an adhesive layer such that a remainder of the skin surface is unrestricted relative to the housing.

36. The method of claim 35 comprising further immobilizing the remainder of the skin surface via a second adhesive layer separated from the adhesive layer such that the remainder of the skin surface is immobilized relative to the housing.

37. The method of claim 30 wherein pumping comprises actuating a pump in fluid communication with the microchannel reservoir and the drug delivery mechanism.

38. The method of claim 37 wherein actuating a pump comprises pumping a gas through the microchannel reservoir such that the one or more drugs are pushed towards the drug delivery mechanism.

39. The method of claim 37 further comprising controlling the pump via an electronic control assembly positioned within or along the housing and in electrical communication with the pump.

40. The method of claim 39 wherein controlling comprises controlling actuation and/or pumping rates of the pump according to a programmable dosage profile.

41. The method of claim 39 wherein controlling comprises actuating a user-activated control for actuating the pump and/or dosage for a predetermined period of time.

42. The method of claim 39 wherein controlling comprises remotely controlling the electronic control assembly via a controller separate from the electronic control assembly.

43. The method of claim 39 further comprising wirelessly communicating with an RFID assembly in communication with the electronic control assembly.

44. The method of claim 30 wherein pumping further comprises infusing a gas into a terminal end of the microchannel reservoir while pumping the one or more drugs contained therein.

45. The method of claim 30 wherein pumping comprises urging a linear actuator to drive a piston head in communication with the microchannel reservoir.

46. The method of claim 45 further comprising detecting a relative position of the piston head.

47. The method of claim 45 wherein urging comprises actuating a piezoelectric transducer vibrationally coupled to the piston head such that vibrating the transducer forces the piston head to rotate and/or translate in an axial direction.

48. The method of claim 45 further comprising sensing a position of the piston head relative to the reservoir such that a differential volume of the reservoir is determined.

49. The method of claim 48 wherein sensing comprises electrically detecting a capacitive difference within a capacitive film contacting the piston head and in electrical communication with one or more sensors positioned along the reservoir.

50. The method of claim 30 wherein the microchannel reservoir has a cross-sectional dimension ranging from 1 micron to 1000 microns.

51. The method of claim 30 wherein the microchannel reservoir has a length ranging from 1 millimeter to 1 meter.

52. The method of claim 30 wherein the microchannel reservoir extends within or along the housing in an alternating back-and-forth pattern over the width and/or length of the housing.

53. The method of claim 30 wherein the elongate microchannel is aligned within a first plane along the housing and further comprising at least a second microchannel aligned within a second plane along the housing which is adjacent to the first plane.

54. The method of claim 30 wherein pumping comprises pumping the one or more drugs from one or more separate microchannels aligned parallel to one another.

55. The method of claim 30 wherein pumping comprises pumping an additional drug to the drug delivery mechanism from at least a second elongate microchannel reservoir located within or along the housing separate from the elongate microchannel.

56. The method of claim 30 further comprising removing or replacing a package or cartridge containing the microchannel reservoir from the housing.

57. A system for transdermal drug delivery, comprising:

a housing configured for placement upon a skin surface;

a drug delivery mechanism within or along the housing positioned to contact the skin surface;

a reservoir contained within or along the housing and fluidly coupled to the drug delivery mechanism; and

a linear actuator having a transducer vibrationally coupled to a translatable element positioned within the reservoir, wherein the translatable element is configured to translate within the reservoir in a controlled manner upon vibrational actuation of the transducer.

58. The system of claim 57 further comprising an electronic control circuitry within or along the housing and in electrical communication with the linear actuator.

59. The system of claim 58 wherein the electronic control circuitry is configured to control actuation of the transducer according to a programmable dosage profile.

60. The system of claim 59 wherein the electronic control circuitry comprises an on-chip clock configured to track a time and/or date of the programmable dosage profile.

61. The system of claim 59 wherein the electronic control circuitry comprises a user-activated control for actuating the transducer and/or dosage for a predetermined period of time.

62. The system of claim 59 wherein the electronic control circuitry comprises an RFID assembly in wireless communication with an external controller.

63. The system of claim 59 further comprising a controller separate from the electronic control assembly and in wireless communication therewith.

64. The system of claim 57 wherein the transducer comprises a piezoelectric transducer.

65. The system of claim 57 wherein the translatable element comprises a piston head positioned within the reservoir.

66. The system of claim 57 wherein actuation of the transducer rotates the element such that the element is translated distally in an axial direction within the reservoir such that a volume of the reservoir is decreased.

67. The system of claim 57 further comprising a positioning sensor assembly configured to sense a position of the translatable element relative to the reservoir such that a differential volume of the reservoir is determined.

68. The system of claim 67 wherein the positioning sensor assembly comprises a capacitive film contacting the translatable element and in electrical communication with one or more sensors positioned along the reservoir.