Microneedle transport device

• US 7,429,258 B2
• Filed: 09/09/2002
• Issued: 09/30/2008
• Est. Priority Date: 10/26/2001
• Status: Expired due to Fees

• Current Assignee: Massachusetts Institute of Technology
• Original Assignee: Massachusetts Institute of Technology
• Inventors: Hunter, Ian W., Angel, Aimee B.
• Primary Examiner(s): Lucchesi; Nicholas D.
• Assistant Examiner(s): Koharski; Christopher
• Application Number:
  US10/238,844
• Publication Number:
  US 20030083645A1
• Time in Patent Office: 2,213 Days
• Field of Search: 604/890.1, 604/891.1, 604/21, 604/22, 604/46, 604/65, 604/66, 604/67, 604/140, 604/141, 604/143, 604/145, 604/150, 604/151, 604/153, 604/156, 604/173, 604/144, 600/347, 600/573, 600/576, 600/578, 600/579
• US Class Current: 604/173
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• 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 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• 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: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

A transdermal transport device includes a reservoir for holding a formulation of an active principle, and an array of needles which have bores in fluid communication with the reservoir to facilitate transporting the formulation to and from the reservoir through the needles. The device also includes a first actuator which drives the array of needles into the body, and a second actuator which pumps the formulation between the reservoir and the body through the needles. The first actuator is reversible to withdraw the needles from the body.

Claims

1. A transdermal transport device for transporting a substance through a surface of a body, comprising:

a plurality of needles;

a first moving interface and a second moving interface; and

a first actuator connected to the first interface, and a second actuator connected to a second interface, the first actuator operating independently with respect to the second actuator;

the first actuator configured to expand the first moving interface to advance the plurality of needles relative to the housing through the surface of the body, and the first actuator being reversible to withdraw the plurality of needles from the body; and

the second actuator configured to expand the second moving interface to transport the substance by moving independently with respect to the first actuator through the surface of the body via the plurality of needles.

2. The transport device of claim 1 wherein the second actuator is reversible to transport the substance from the body.

3. The transport device of claim 2 wherein the substance is collected from the body.

4. The transport device of claim 1 wherein the plurality of needles are positionable in a retracted state when the first actuator is de-energized.

5. The transport device of claim 1 further comprising one or more controllers, wherein at least one of the first and the second actuators is under the direction of the one or more controllers.

6. The transport device of claim 1 wherein at least one of the first and the second actuators includes a vapor generator.

7. The transport device of claim 1 wherein at least one of the first and the second actuators operates by a chemical reaction process.

8. The transport device of claim 1 wherein at least one of the first and the second actuators operates by an electrochemical process.

9. The transport device of claim 1 further comprising an oscillator which causes the plurality of needles to vibrate to reduce a force required to advance the needles through the surface of the body.

10. The transport device of claim 9 wherein the oscillator is a piezoelectric crystal.

11. The transport device of claim 1 further comprising a sensor to monitor a status of the body.

12. The transport device of claim 11 wherein the status is a glucose concentration.

13. The transport device of claim 12 wherein the substance is insulin pumped into the body, the amount of insulin pumped into the body being based on the glucose concentration.

14. The transport device of claim 11 comprising a controller in communication with the sensor, wherein the controller controls at least one of the first and second actuators.

15. The transport device of claim 1 wherein the first actuator is contained in a control unit, and the second actuator and the plurality of needles are contained in a cartridge, the control unit and the cartridge being separately connectable units with respect to one another.

16. The transport device of claim 1 wherein a depth of penetration by the plurality of needles is between about 50 μ

m and 300 μ

m.

17. The transport device of claim 1 wherein a depth of penetration by the plurality of needles is no more than about 200 μ

m.

18. The transport device of claim 1 further comprising a controller to control the first actuator.

19. The transport device of claim 18 wherein the controller controls the depth of penetration by the plurality of needles.

20. The transport device of claim 19 wherein the controller controls the depth of penetration using a parameter selected from the group consisting of:

needle diameter;

angle of insertion with respect to the surface of the body;

insertion velocity;

peak insertion force; and

combinations thereof.

21. The transport device of claim 20 further comprising a controller to control the second actuator.

22. The transport device of claim 21 wherein the controller controls a dose of the substance.

23. The transport device of claim 22 wherein the controller controls the dose of the substance using a parameter selected from the group consisting of:

transport time;

volume;

transport rate; and

combinations thereof.

24. The transport device of claim 1 wherein the second actuator is controllable for intermittent transportation of the substance through the surface of the body.

25. The transport device of claim 1 wherein the first actuator is adapted to contract to withdraw the advanced plurality of needles from the body.

26. The transport device of claim 1 wherein the second actuator has a chamber that changes volume to transport the substance through the surface of the body via the needles.

27. The transport device of claim 1 wherein the first actuator is controllable to advance the plurality of needles at a predetermined force versus penetration depth.

28. The transport device of claim 1 wherein a penetration depth is achieved by varying a parameters selected from the list of parameters including:

needle diameter;

angle of insertion with respect to the surface of the body;

insertion velocity;

peak insertion force; and

combinations thereof.

29. The transport device of claim 1 further comprising a plenum, the plurality of needles being moveable through the plenum to clean the needles.

30. The transport device of claim 1 wherein the device is adapted to be attached to the body.

31. The transport device of claim 30 wherein the device remains attached during the transportation of the substance.

32. The transport device of claim 1 wherein each of the first and second actuators is automated.

33. The transport device of claim 1 further comprising a means for attaching the device to the surface of the body.

34. The transport device of claim 1 wherein the first and second actuators transport a first substance from the body and transport a second substance from the body.

35. A transdermal transport device for transporting a substance through a surface of a body, comprising:

a plurality of needles; and

a vapor generator actuator to transport the substance through the surface of the body via the needles, the vapor generator actuator comprising;

an enclosed chamber containing a liquid;

a moving interface separating the liquid from the substance; and

a heater for heating the liquid to expand the volume of the liquid to force the moving interface against the liquid to pump the substance through the needle.

36. The transport device of claim 35 further comprising a second actuator which advances the plurality of needles through the surface of the body, the second actuator being reversible to withdraw the plurality of needles from the body.

37. The transport device of claim 36 wherein the second actuator is contained in a control unit, and the vapor generator actuator and the plurality of needles are contained in a cartridge, the control unit and the cartridge being separately connectable units with respect to one another.

38. The transport device of claim 36 wherein the second actuator is a second vapor generator actuator.

39. The transport device of claim 36 further comprising an oscillator which causes the plurality of needles to vibrate to reduce the force required to advance the needles through the surface of the body.

40. The device of claim 35 wherein the substance is collected from the body.

41. The transport device of claim 35 wherein the plurality of needles is positionable in a retracted state when the vapor generator actuator is de-energized.

42. The transport device of claim 35 further comprising a controller, the vapor generator actuator being under the direction of the controller.

43. The transport device of claim 35 further comprising a sensor to monitor a status of the body.

44. The transport device of claim 43 wherein the status is a glucose concentration.

45. The transport device of claim 44 wherein the substance is insulin pumped through the surface of the body, the amount of insulin pumped being based on the glucose concentration.

46. The transport device of claim 35 wherein the vapor generator actuator is automated.

47. A transdermal transport device for transporting a substance through a surface of a body, comprising:

a plurality of needles;

a first vapor generator actuator to drive the plurality of needles through the surface of the body; and

a second vapor generator actuator to transport the substance through the needles and through the surface of the body.

48. The transport device of claim 47 wherein each of the first and second actuators is automated.

49. A transdermal transport device for transporting a substance through a surface of a body, comprising:

a means for moving a reservoir towards the body and driving a plurality of needles into the body, each needle having a bore in fluid communication with the reservoir; and

a means for transporting the substance from the reservoir through the needles into the body.

50. The transport device of claim 49 wherein the means for transporting the substance is automated.

51. A method of transporting a substance through a surface of a body, comprising:

placing a delivery device at the body; and

transporting the substance through the surface of the body via a plurality of needles with a first actuator, the first actuator comprising;

an enclosed chamber containing a liquid;

a moving interface separating the liquid from the substance; and

a heater for heating the liquid to expand the volume of the liquid to force the moving interface against the liquid to pump the substance through the needle.

52. The method of claim 51 further comprising driving the plurality of needles through the surface of the body with a second actuator.

53. The method of claim 52 further comprising generating a vibration in the plurality of needles to reduce a force required to advance the needles through the surface of the body.

54. The method of claim 52 wherein the second actuator is a second vapor generator actuator.

55. The transport device of claim 52 wherein the second actuator has a chamber that changes volume to transport the substance between the reservoir and the body through the needles.

56. The method of claim 52 further comprising generating a vibration in the plurality of needles to reduce a force required to advance the needles through the surface of the body.

57. The method of claim 56 wherein the body is a drug vial and transporting includes drawing the substance from the drug vial into the reservoir.

58. The method of claim 51 wherein the first actuator advances the plurality of needles to a depth of penetration no more than about 200 μ

m.

59. The method of claim 51 wherein the first actuator advances the plurality of needles to a depth of penetration between about 50 μ

m and about 300 μ

m.

60. The method of claim 51 wherein the transporting is from a reservoir into the body.

61. The method of claim 51 further comprising attaching the device to the body.

62. The method of 51 wherein the first actuator is automated.

63. A method of transdermally transporting a substance through a surface of a body, comprising:

placing a delivery device at the body;

moving a reservoir holding the substance towards the body and advancing a plurality of needles connected in fluid communication with the reservoir, into the body with a first vapor generator actuator while generating longitudinal vibrations along the lengths of the plurality of needles to reduce a force required to advance the needles into the body; and

transporting the substance from the reservoir though the plurality of needles into the body with a second vapor generator actuator.

64. The method of claim 63 wherein the first actuator advances the plurality of needles to a depth of penetration no more than about 200 μ

m.

65. The method of claim 63 wherein the first actuator advances the plurality of needles to a depth of penetration between about 50 μ

m and about 300 μ

m.

66. The method of claim 63 wherein the substance is transported through the plurality of needles intermittently.

67. The method of claim 63 wherein the transporting is from a reservoir into the body.

68. The method of claim 63 further comprising attaching the device to the body.

69. The method of 63 wherein each of the first and second vapor generator actuators is automated.

70. A transdermal transport device for transporting a substance through a surface of a body, comprising:

a plurality of needles;

an actuator to advance the plurality of needles into the body; and

a reversible actuator to selectively transport the substance in a first direction across the surface of the body via the plurality of needles and in a different direction across the surface of the body via the plurality of needles.

71. The transport device of claim 70 further comprising a controller, wherein the actuators is under the direction of the controller.

72. The transport device of claim 70 wherein the actuator includes a vapor generator.

73. The transport device of claim 70 wherein each of the actuator and the reversible actuator is automated.