Microneedle transdermal transport device

• US 7,364,568 B2
• Filed: 10/21/2002
• Issued: 04/29/2008
• 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): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/278,049
• Publication Number:
  US 20030083619A1
• Time in Patent Office: 2,017 Days
• Field of Search: 604/890.1, 604 21- 22, 604/35, 604/48, 604/504, 604/513, 604 65- 66, 604/115, 604/128, 604/133, 604/139, 604140-141, 604/143, 604/145, 604/153, 604/156, 604/173, 604/176, 604/239, 604/258, 604/272
• 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 a needle with a bore extending along the length of the needle from a first end of the needle to a second end of the needle. The second end is substantially aligned to a plane parallel to a body surface of a biological body when the device is placed on the body surface. The device also includes an actuator which pumps the formulation through the bore of the needle between a target area of the body and the reservoir.

Claims

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

a plurality of needles configured substantially parallel to the surface of the body to independently and removably secure the device to the surface of the body, each of the needles having a bore therethrough for transporting the substance to a target area of the body and at least two of the plurality of needles each piercing the body surface from a different respective direction; and

an actuator which transports the substance through at least one of the plurality of needles and through the surface of the body.

2. The transport device of claim 1, further comprising means for moving a first and second respective portions of the body surface wherein a first needle of the plurality of needles substantially laterally pierces the first respective moved portion of the body surface, but not the second moved portion, and the second needle of the plurality of needles substantially laterally pierces the second moved portion of the body surface, but not the first moved portion.

3. The transport device of claim 2, wherein the moving means comprises a vacuum.

4. The transport device of claim 2, wherein each of the first and second needles substantially laterally pierces its respective moved portion from a different respective direction.

5. The transport device of claim 2, wherein the means for moving comprises a means for raising the first and second respective portions of the body surface.

6. The transport device of claim 2, wherein the different respective directions differ by a nonzero angle.

7. The transport device of claim 2 further comprising a controller which controls the device.

8. The transport device of claim 1 wherein the actuator transports the substance into the biological body.

9. The transport device of claim 1 wherein the actuator transports the substance from the body to a reservoir.

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

11. The transport device of claim 1 further comprising an oscillator which causes at least one of the plurality of needles to vibrate along its length to reduce the force required to drive the needle into the body.

12. The transport device of claim 1 further comprising a sensor to monitor the status of a patient.

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

14. The transport device of claim 13 wherein the substance that the actuator translates through the surface is insulin and wherein an amount of insulin is based on the glucose concentration.

15. The transport device of claim 1 further comprising a base unit and a control unit separable from each other, the plurality of needles and actuator being located within the base unit, the first and second moved portions being at least partially moved within the base unit.

16. The transport device of claim 1 wherein at least one of the plurality of needles defines an opening through which the substance is transported, the opening being directed towards the body surface.

17. The transport device of claim 1 further comprising a controller which controls the device.

18. The transport device of claim 1 wherein each of the plurality of needles has a respective outer diameter of less than about 250 μ

m.

19. The transport device of claim 1 wherein each of the plurality of needles has a respective inner diameter of less than about 100 μ

m.

20. The transport device of claim 1 wherein each of the plurality of needles includes a bend.

21. The transport device of claim 1, wherein the actuator transports the substance through at least two needles.

22. The transport device of claim 1, further comprising a reservoir for holding the substance.

23. The transport device of claim 1 wherein at least two of the plurality of needles each pierce the body surface from a different respective direction.

24. The transport device of claim 1 wherein three or more of the plurality of needles each pierce a respective portion of the body surface from a different respective direction.

25. The transport device of claim 1, further comprising a plurality of guide sleeves, each of the plurality of needles guidable within a respective one of the guide sleeves through which the needle is guided into the skin.

26. The transport device of claim 1, further comprising an actuator to move the plurality of needles out of the body to disengage the delivery device from the body surface.

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

a plurality of needles configured to attach the device to the surface of the body; and

an actuator which transports the substance through at least one of the plurality of needles and through the surface of the body and moves at least one of the plurality of needles around an axis.

28. The transport device of claim 27, wherein the at least one needle is moved rotationally around an axis to substantially laterally pierce a respective portion of the surface.

29. The transport device of claim 27, wherein at least two of the plurality of needles are moved by a rotary actuator to substantially laterally pierce a respective first and second portions of the surface.

30. The transport device of claim 27 wherein the rotary actuator moves an end portion of at least one of the plurality of needles in a plane substantially parallel to the surface.

31. The transport device of claim 27 wherein the actuator rotates each of the plurality of needles about an axis.

32. A transport device for delivering a substance to a body having a surface, comprising:

a reservoir for holding the substance;

a needle configured to independently secure the device to the body, and through which the substance is transported between the reservoir and the body;

an actuator which transports the substance between the reservoir and the body;

a sensor that measures a status of the body; and

a controller which directs the actuator to transport a desired amount of the substance, the desired amount being dependent on the measured status.

33. The transport device of claim 32 wherein the desired amount of the substance is delivered over a particular time period.

34. The transport device of claim 33, wherein the time period is more than one day.

35. The transport device of claim 33 wherein the time period is more than 1 sec.

36. The transport device of claim 32 wherein the desired amount of the substance is delivered incrementally over time.

37. The transport device of claim 32 wherein the body is a human patient.

38. The transport device of claim 32 wherein one or more of the plurality of needles collects a sample from the body, the sensor measuring the collected sample.

39. The transport device of claim 32, wherein the surface is skin.

40. A method of transporting a substance, comprising:

placing a delivery device with a reservoir for holding the substance on a body surface of a biological body;

inserting a plurality of needles into the body, the plurality of needles configured substantially parallel to the surface of the body to independently secure the device to the body surface and at least two of the plurality of needles each piercing the body surface from a different respective direction;

transporting the substance through a bore of at least one of the plurality of needles between a target area of the body and the reservoir; and

controlling the transporting of the substance being dependent on a status of the body.

41. A substance transport device, comprising:

means for holding a substance;

needle means for independently securing the device to a surface of a body;

means for transporting the substance between the means for holding and a target area of the body; and

means for transporting the substance between the target area of the body and the first end of the means for holding.

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

a plurality of needles configured to attach the device to the surface of the body and rotatable about an axis for attaching the device to the surface of the body; and

an actuator which transports the substance through at least one of the plurality of needles and through the surface of the body.

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

a plurality of needles configured to attach the device to the surface of the body;

an actuator which transports the substance through at least one of the plurality of needles and through the surface of the body;

means for moving a first and second respective portions of the body surface wherein a first needle of the plurality of needles substantially laterally pierces the first respective moved portion of the body surface, but not the second moved portion, and the second needle of the plurality of needles substantially laterally pierces the second moved portion of the body surface, but not the first moved portion; and

first and second ports into which first and second respective portions of the body surface are moved.

44. The transport device of claim 43, wherein the directions differ by a nonzero angle.

45. The transport device of claim 43, wherein the directions differ with respect to each other by an angle less than 180 degrees.

46. The transport device of claim 43, wherein each of the at least two needles pierces a different respective portion of the surface.

47. The transport device of claim 43, wherein each of the three or more needles pierces a different respective portion of the surface.

48. A transport device for delivering a substance to a body having a surface, comprising:

a reservoir for holding the substance;

a needle configured to attach the device to the body, and through which the substance is transported between the reservoir and the body;

an actuator which transports the substance between the reservoir and the body;

a sensor that measures a status of the body;

a controller which directs the actuator to transport a desired amount of the substance, the desired amount being dependent on the measured status; and

a second needle which pierces the surface of the body at a different respective angle from the first needle.

49. A method of transporting a substance, comprising:

placing a delivery device with a reservoir for holding the substance on a body surface of a biological body;

inserting a plurality of needles into the body, the plurality of needles configured substantially parallel to the surface of the body to removably attach the device to the body surface, at least two of the plurality of needles each piercing the body surface from a different respective direction;

transporting the substance through a bore of at least one of the plurality of needles between a target area of the body and the reservoir; and

controlling the transporting of the substance being dependent on a status of the body.

50. A substance transport device, comprising:

means for holding a substance;

needle means for attaching the device to a surface of a body;

means for transporting the substance between the means for holding and a target area of the body; and

means for transporting the substance between the target area of the body and the first end of the means for holding;

a second needle means which pierces the surface of the body at a different respective angle from the first needle means.