Method and delivery device for the transdermal administration of a substance

• US 6,656,147 B1
• Filed: 07/17/2000
• Issued: 12/02/2003
• Est. Priority Date: 07/17/2000
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Gertsek, Marina, Pettis, Ronald J., Wilkinson, Bradley M.
• Primary Examiner(s): MAUST, TIMOTHY LEWIS
• Application Number:
  US09/617,355
• Time in Patent Office: 1,233 Days
• Field of Search: 604/27, 604/3, 604/19, 604/290, 604/289, 604/87, 604/181, 604/182, 604/306, 604/310, 604/311, 604/185, 604/212, 604/218, 604/28
• US Class Current: 604/28
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• 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

Abstract

A device for delivering a substance into the skin of a patient includes a housing and a plurality of microneedles for penetrating the skin. The housing includes a bottom wall with a plurality of apertures for supplying the substance to the microneedles. The housing also includes a flexible top cover member enclosing a bladder containing the substance to be delivered. The bottom wall of the housing has at least one cannula facing the bladder. Pressing on the top cover member causes the cannula to puncture the bladder and deliver the substance to the microneedles for delivery to the patient. In one embodiment, the cannula is surrounded by a flexible member to prevent piercing of the bladder until sufficient pressure is applied to the cover member to depress the flexible member.

Claims

1. A device for introducing a substance into the skin of a patient, said device comprising:

a housing having a central opening;

a planar member positioned in said central opening of said housing, said planar member having an inner surface and an outer surface, said outer surface having a plurality of microneedles extending therefrom, at least one opening passing through said planar member from said inner surface to said outer surface, and at least one cannula on said inner surface;

a flexible, deformable cover coupled to said housing and overlying said central opening and being spaced from said planar member to define a cavity in said housing; and

a bladder containing at least one substance and being positioned in said cavity of said housing between said planar member and said flexible cover, said bladder being piercable by said cannula and collapsible by pressing and deforming said flexible cover to dispense said substance through said opening to said microneedles.

2. The device of claim 1, further comprising a dry pharmaceutical agent, wherein said substance contained in said bladder is a diluent.

3. The device of claim 2, wherein said dry pharmaceutical agent is provided in said at least one opening in said planar member.

4. The device of claim 2, wherein said dry pharmaceutical agent is provided on said microneedles.

5. The device of claim 2, wherein said dry pharmaceutical is provided on said inner surface of said planar member.

6. The device of claim 1, wherein said dry pharmaceutical agent is provided in said cavity.

7. The device of claim 1, wherein said cannula is a substantially conical shaped member having a tip facing said bladder.

8. The device of claim 1, wherein said cannula is integrally formed on said inner surface of said planar member.

9. The device of claim 1, wherein said microneedles have a length for penetrating the stratum corneum of the skin.

10. The device of claim 1, comprising a plurality of said openings in said planar member, said openings extending through a respective microneedle.

11. The device of claim 1, wherein said at least one opening in said planar member is adjacent at least one of said microneedles.

12. The device of claim 1, wherein said flexible cover is made of a resilient material and movable from a first position having a generally convex outer surface to a second position having a generally concave outer surface.

13. The device of claim 12, wherein said flexible cover is made from a stiff plastic material having a memory and is able to snap from said first position to said second position.

14. The device of claim 1, wherein said microneedles have a length of about 10 to 40 microns.

16. The device of claim 1, further comprising a flexible film having a bottom face attached to said housing, said flexible film surrounding said housing and extending outwardly therefrom, and an adhesive on said bottom face for attaching said device to the skin of a patient.

17. The device of claim 1, further comprising a protecting member on said inner surface of said bottom wall, said protecting member having a height greater than a height of said cannula and being positioned to prevent said bladder from contacting said cannula until sufficient pressure is applied to said flexible cover.

18. The device of claim 17, wherein said protecting member includes a base coupled to said inner surface of said bottom wall, and having at least one flexible arm coupled to said base and extending in a direction toward said bladder, said at least one arm having a length to prevent said bladder from contacting said cannula and being sufficiently flexible, wherein a force applied to said flexible cover flexes said arm toward said bottom wall whereby said bladder contacts said cannula.

19. The device of claim 1, wherein said housing includes an indicating device for indicating contact of said device with the skin of a patient.

20. The device of claim 19, wherein said indicating device includes a pair of electrodes for contacting the skin, a power source coupled to said electrodes and an indicator coupled to said power source and said electrodes.

15. A device for introducing a substance into the skin of a patient, said device comprising:

a housing having a central opening;

a bottom member positioned in said central opening of said housing, said member having an inner surface and an outer surface, said outer surface having a plurality of microneedles extending therefrom, at least one opening passing through said member from said inner surface to said outer surface, and at least one cannula;

a flexible cover coupled to said housing and overlying said central opening and being spaced from said member to define a cavity in said housing, wherein said housing has a bottom surface surrounding said member, said device further comprising an adhesive on said bottom surface for attaching said housing to the skin of a patient; and

a bladder containing at least one substance and being positioned in said cavity of said housing between said member and said flexible cover, said bladder being piercable by said cannula and collapsible by pressing said flexible cover to dispense said substance through said opening to said microneedles.

21. A delivery device for delivering a substance to the skin of a patient, said device comprising:

a housing having a bottom wall and at least one side wall defining a cavity, said bottom wall having a plurality of microneedles and a plurality of passages extending through said bottom wall to said microneedles;

a flexible cover coupled to said housing and enclosing said cavity, said flexible cover having a generally arcuate shaped outer surface in a first position and being deformable from said first position to a second position toward said bottom wall; and

a bladder containing a substance, said bladder being positioned in said cavity and being collapsible by applying pressure to said flexible cover to dispense said substance through said passages in said bottom wall to said microneedles.

22. The delivery device of claim 21, wherein said substance contained in said bladder is a diluent and said cavity contains at least one dried pharmaceutical agent that is soluble or dispersible in said diluent.

23. The delivery device of claim 21, wherein said substance contained in said bladder is a diluent and said microneedles include a coating of at least one dried pharmaceutical agent that is soluble or dispersible in said diluent.

24. The delivery device of claim 21, further comprising a cannula in said cavity and being positioned to pierce said bladder by applying sufficient force to said flexible cover.

25. The delivery device of claim 24, wherein said cannula is positioned on said bottom wall of said housing.

26. The delivery device of claim 21, wherein said microneedles are hollow to form a passage from said cavity to a tip of said microneedles.

28. The delivery device of claim 24, further comprising a protecting member on an inner surface of said bottom wall, said protecting member having a height greater than a height of said cannula and being positioned to prevent said bladder from contacting said cannula until sufficient pressure is applied to said flexible cover.

29. The delivery device of claim 28, wherein said protecting member includes a base coupled to said inner surface of said bottom wall, and having at least one flexible arm coupled to said base and extending in a direction toward said bladder, said flexible arm being sufficiently flexible to bend toward said bottom wall by applying sufficient pressure to said cover member, whereby said cannula pierces said bladder.

27. A delivery device for delivering a substance to the skin of a patient, said device comprising:

a housing having a bottom wall and at least one side wall defining a cavity, said bottom wall having a plurality of microneedles and a plurality of passages extending through said bottom wall to said microneedles;

a flexible cover coupled to said housing and enclosing said cavity, said flexible cover having a generally arcuate shaped outer surface in a first position and being movable from said first position to a second position toward said bottom wall;

a bladder containing a substance, said bladder being positioned in said cavity and being collapsible by applying pressure to said flexible cover to dispense said substance through said passages in said bottom wall to said microneedles; and

a flexible film attached to said housing, said film surrounding said housing and extending outwardly therefrom, and having an adhesive on a bottom face for attaching said delivery device to the skin of a patient.

30. A method of administering a substance through the skin of a patient, comprising the steps of

providing a delivery device having a housing with a bottom wall and at least one side wall defining a cavity, said bottom wall having an outer surface with a plurality of microneedles extending therefrom and having a plurality of passages extending through said bottom wall from said cavity to said microneedles, a bladder containing at least one substance and being positioned in said cavity, and a flexible, deformable cover enclosing said cavity;

contacting said device to the skin of a patient and applying sufficient pressure to said device to cause said microneedles to penetrate the skin a sufficient depth for delivering said substance to the patient; and

applying sufficient pressure to said flexible cover-to rupture said bladder and dispense said substance to said microneedles.

31. The method of claim 30, wherein said device includes a dry pharmaceutical agent and said substance contained in said bladder is a diluent.

32. The method of claim 30, wherein said dry pharmaceutical agent is provided in said cavity.

33. The method of claim 30, wherein said device includes a cannula positioned in said cavity and having a tip positioned for piercing said bladder, said method comprising applying sufficient pressure to said cover to cause said cannula to pierce said bladder.

34. The method of claim 33, wherein said cannula is integrally formed on an inner surface of said bottom wall.

35. The method of claim 30, wherein said passages in said bottom wall are adjacent said microneedles.

36. The method of claim 30, wherein said flexible cover is made of a resilient material and movable from a first position having a generally convex outer surface to a second position having a generally concave outer surface.

37. The method of claim 30, said device further comprising a flexible film having a bottom face attached to said housing, said flexible film surrounding said housing and extending outwardly therefrom, and an adhesive on said bottom face, said method comprising pressing said flexible film to attach said device to the skin of a patient.

38. A method of administering a substance through the skin of a patient, comprising the steps of

providing a delivery device having a housing with a bottom wall and at least one side wall defining a cavity, said bottom wall having an outer surface with a plurality of microneedles extending therefrom and having a plurality of passages extending through said bottom wall from said cavity to said microneedles, a bladder containing at least one substance and being positioned in said cavity, and a flexible, deformable cover enclosing said cavity;

said device further comprising a resilient protecting member on said inner surface of said bottom wall, said protecting member having a height greater than a height of said cannula and being positioned to prevent said bladder from contacting said cannula, said method comprising pressing said cover with sufficient pressure to push said bladder into contact with said cannula to pierce said bladder;

contacting said device to the skin of a patient and applying sufficient pressure to said device to cause said microneedles to penetrate the skin a sufficient depth for delivering said substance to the patient; and

applying sufficient pressure to said flexible cover to rupture said bladder and dispense said substance to said microneedles.

39. The method of claim 38, wherein said protecting member includes a base coupled to said inner surface of said bottom wall, and having at least one flexible arm coupled to said base and extending in a direction toward said bladder, said at least one arm having a length to prevent said bladder from contacting said cannula, said method comprising applying sufficient pressure to said cover to flex said arm toward said bottom wall whereby said bladder is pierced by said cannula.

40. A device for introducing a substance into the skin of a patient, said device comprising:

a housing having a central opening;

a bottom member positioned in said central opening of said housing, said member having an inner surface and an outer surface, said outer surface having a plurality of microneedles extending therefrom, at least one opening passing through said member from said inner surface to said outer surface;

a flexible cover coupled to said housing and overlying said central opening and being spaced from said member to define a cavity in said housing;

a cannula extending into said central opening;

a bladder containing at least one substance and being positioned in said cavity of said housing between said member and said flexible cover, said bladder being piercable by said cannula and collapsible by pressing said flexible cover to dispense said substance through said opening to said microneedles; and

a protecting member in said cavity to prevent said bladder from contacting said cannula until sufficient pressure is applied to said flexible cover.

41. The device of claim 40, wherein said protecting member surrounds said cannula.

42. The device of claim 40, wherein said cannula is on said inner surface of said bottom member.

43. The device of claim 42, wherein said protecting member is on said inner surface of said bottom member.

44. The device of claim 40, wherein said protecting member has a height greater than a height of said cannula.

45. The device of claim 44, wherein said protecting member is a flexible member and deforms when a sufficient pressure is applied to said cover.

46. The device of claim 44, wherein said protecting member includes a flexible arm, said arm being sufficiently flexible to bend toward said bottom wall by applying sufficient pressure to said cover member.

47. The device of claim 40, wherein said protecting member includes a base and at least one flexible arm coupled to said base and extending in a direction toward said bladder a distance to prevent said bladder from contacting said cannula.

48. The device of claim 47, wherein said at least one flexible arm is sufficiently flexible to bend toward said base by applying sufficient pressure to said bladder.

49. A delivery device for delivering a substance to the skin of a patient, said device comprising:

a housing having a bottom wall and at least one side wall defining a cavity, said bottom wall having a plurality of microneedles and a plurality of passages extending through said bottom wall to said microneedles;

a flexible cover having an outer portion coupled to said housing and a central portion enclosing said cavity, said outer portion of said flexible cover being deformable from a first position spaced from said bottom wall to a second position toward said bottom wall; and

a bladder containing a substance, said bladder being positioned in said cavity and being collapsible by applying pressure to said flexible cover to dispense said substance through said passages in said bottom wall to said microneedles.

50. The delivery device of claim 49, wherein said bottom wall has an outer edge surrounding said microneedles and an adhesive on said outer edge for attaching said housing to the skin of a patient.

51. The delivery device of claim 49, further comprising a flexible film attached to said housing and extending outwardly therefrom, and an adhesive on a bottom face of said flexible film for attaching said device to the skin of a patient.

52. The delivery device of claim 49, further comprising a cannula positioned in said cavity for piercing said bladder and a protecting member positioned in said cavity to prevent said cannula from piercing said bladder until sufficient pressure is applied to said bladder.

53. The delivery device of claim 52, wherein said protecting member includes at least one flexible arm.

55. The delivery device of claim 53, wherein said protecting member surrounds said cannula.

54. A delivery device for delivering a substance to the skin of a patient, said device comprising:

a housing having a bottom wall and at least one side wall defining a cavity, said bottom wall having a plurality of microneedles and a plurality of passages extending through said bottom wall to said microneedles and a cannula extending into said cavity;

a bladder containing a substance, said bladder being positioned in said cavity and being collapsible by applying pressure to said bladder toward said bottom wall to dispense said substance through said passages in said bottom wall to said microneedles; and

a protecting member positioned in said cavity to prevent said bladder from contacting said cannula until sufficient pressure is applied to said bladder.

56. The delivery device of claim 54, wherein said protecting member has a height greater than a height of said cannula.

57. The delivery device of claim 56, wherein said protecting member has at least one flexible arm extending in a direction toward said bladder.