Microdevice and method of delivering or withdrawing a substance through the skin of an animal

• US 6,689,100 B2
• Filed: 10/05/2001
• Issued: 02/10/2004
• Est. Priority Date: 10/05/2001
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pettis, Ronald J., Connelly, Robert I.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/971,145
• Publication Number:
  US 20030069548A1
• Time in Patent Office: 858 Days
• Field of Search: 604/506, 604/513, 604/174, 604/180, 604/257, 604/272, 604/288.04, 604/46, 604/117, 604/890.1, 604/48, 604/507, 604/93.01, 604/103.01, 604/115, 604/19, 604/239, 604/264, 604/274, 604/289
• US Class Current: 604/117
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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

Abstract

A device for withdrawing or delivering a substance through the skin of a patient includes a body and a skin penetrating device having a plurality of skin penetrating members, such microneedles. The body includes a bottom surface having a first inner surface area supporting the skin penetrating members and a second outer surface having an adhesive for attaching the device to the skin. In one embodiment, the firs inner surface is spaced outwardly from the second outer surface when the device is attached to the skin. The inner surface can have a textured visually wettable surface, such as an etched surface, to provide a visual indication of leakage from the interface between the skin penetrating members and the skin.

Claims

1. A device for intradermally delivering or withdrawing a substance through at least one layer of the skin of a patient, said device comprising:

a body having a bottom face, a top face spaced from said bottom face, a side edge, and a width, said body having a height extending between said top face and said bottom face that is less than said width, said body defining a channel extending longitudinally from said edge, substantially parallel to said bottom face;

a skin penetrating device coupled to said bottom face and being in fluid communication with said channel, said skin penetrating device comprises a base and a plurality of skin penetrating members arranged in an array and extending outwardly from said base; and

wherein said body defines a recess in said bottom face, said recess being dimensioned to receive said skin penetrating device, said skin penetrating device being mounted in said recess, and wherein said channel is in fluid communication with said recess for supplying the substance to said skin penetrating device.

2. The device of claim 1, wherein said base has a substantially planar bottom face and said skin penetrating device is mounted in said recess whereby said bottom face of said base is oriented in substantially the same plane as said bottom face of said body.

3. The device of claim 1, wherein said bottom face of said body has a substantially planar first surface area and a substantially planar second surface area, the second surface area being arranged adjacent said first surface area, wherein said first surface area is spaced outwardly from said second surface area and said skin penetrating device is arranged in said first surface area.

4. The device of claim 3, wherein said second surface area surrounds said first surface area and an adhesive layer is provided on said second surface area for attaching said device to the skin of said patient.

5. The device of claim 3, wherein said second surface area includes an adhesive for attaching said second surface area to the skin of said patient, whereby said skin penetrating device contacts said skin with a pressure sufficient to penetrate said skin.

6. The device of claim 3, wherein said first surface area of said bottom face includes a leak detector for indicating leakage of said substance from an interface between said skin penetrating device and said skin of said patient.

7. The device of claim 6, wherein said leak detector comprises a surface texture on said first surface area for visually indicating contact of said first surface area with a liquid.

8. The device of claim 7, wherein said body is made of a material having a clarity sufficient to view said leak detector through said top surface of said body.

9. The device of claim 1, wherein said body is made from a resilient plastic material.

10. The device of claim 1, wherein said skin penetrating device includes a base and a plurality of skin penetrating members arranged in an array on said base, said skin penetrating members have a length of about 50 microns to about 4,000 microns.

11. A device for intradermally delivering or withdrawing a substance through at least one layer of the skin of a patient, said device comprising:

a body having a top face and a bottom face, said bottom face having a first surface area lying in a first plane and a second surface area lying in a second plane, said first surface area being spaced outwardly from said second surface area; and

a skin penetrating device extending from said first surface area of said bottom face and being oriented to penetrate the surface of said skin of said patient; and

wherein said bottom face includes a leak detector for indicating leakage of said substance from between said skin penetrating device and said skin of said patient.

12. The device of claim 11, wherein said second surface area surrounds said first surface area.

13. The device of claim 11, wherein an adhesive is arranged in said second surface area for attaching said device to said skin of said patient.

14. The device of claim 13, wherein said first surface area is spaced outwardly from said second surface area a distance to apply a pressure to said skin sufficient to cause said skin penetrating device to penetrate said skin when said second surface area is attached to said skin.

15. The device of claim 11, wherein said skin penetrating device comprises a base and a plurality of skin penetrating members arranged in an array and extending outwardly from said base.

16. The device of claim 15, wherein said skin penetrating members have a length of about 50 microns to about 4,000 microns.

17. The device of claim 11, wherein said leak detector comprises a visible surface texture on said first surface area for visualizing contact of said bottom face of said first surface area with the substance, and wherein said visible surface texture is visible through said top face.

18. The device of claim 17, wherein said visible surface texture comprises a plurality of microscratches on said first surface area of said bottom face.

19. The device of claim 17, wherein said visible surface texture comprises an etched surface on said first surface area of said bottom face.

20. A device for intradermally delivering or withdrawing a substance through at least one layer of the skin of a patient, said device comprising:

a body having a top face and a bottom face; and

at least one skin penetrating member coupled to said body and extending outwardly from said bottom face;

said bottom face having a first surface area surrounding said at least one skin penetrating member, said first surface area having a leak detector for indicating the presence of a substance in contact with said bottom face.

21. The device of claim 20, wherein said leak detector comprises a visual leak indicator on said first area of said bottom face.

22. The device of claim 21, wherein said top surface is transparent such that said visual leak indicator is visible.

23. The device of claim 21, wherein said visual leak indicator comprises a plurality of microscratches in said first surface area.

24. The device of claim 21, wherein said visual leak indicator comprises an etched surface on said first area.

25. The device of claim 21, wherein said visual leak indicator encircles said skin penetrating member.

26. A method of delivering or withdrawing a substance through at least one layer of the skin of a patient, said method comprising the steps of:

providing a device having a body with a bottom face, at least one skin penetrating device arranged on said bottom face, said bottom face including a first surface area arranged in a first plane and surrounding said skin penetrating device and a second surface area arranged in a second plane, said first surface area being spaced outwardly from said second surface area and having a leak detector;

positioning said skin penetrating device on a target site of said skin of said patient;

applying a pressure against said device sufficient for said skin penetrating device to penetrate said skin and for said second surface area to contact said skin; and

delivering a substance to or withdrawing a substance from said target site of said patient.

27. The method of claim 26, further comprising adhesively attaching said second surface area to said skin.

28. The method of claim 26, wherein said second surface area surrounds said first surface area.

29. The method of claim 28, wherein said skin penetrating members have a length of about 50 microns to about 4,000 microns.

30. The method of claim 26, wherein said skin penetrating device comprises a base and an array of a plurality of skin penetrating members extending from said base.

31. The method of claim 30, wherein said base has a planar bottom face and said bottom face of said base is oriented in said first plane.

32. The method of claim 26, wherein said device has an internal channel extending between an inlet and said at least one skin penetrating device, said method comprising supplying a substance through said internal channel to said skin penetrating device.

33. The method of claim 26, wherein said leak indicator comprises a plurality of microscratches on said first surface area.

34. The method of claim 26, wherein said leak indicator comprises an etched surface on said first surface area.

35. A microdevice interface, comprising:

a body having a top face and a bottom face, said bottom face having a first surface area and a second surface area, said first surface area being raised from said body with respect to said second surface area;

a recess defined in said first surface area said recess having a height that is less than a width;

an opening defined in said body for fluid flow into and out of said body, said opening being in fluid communication with said recess;

wherein said opening and said recess are in fluid communication via a second opening, said second opening being perpendicular to a plane of the device.

36. The interface of claim 35, further comprising a skin penetrating device arranged in said recess.

37. The interface of claim 35, wherein said second surface area includes an adhesive for attaching said second surface area to the skin of said patient, whereby said skin penetrating device contacts said skin with a pressure sufficient to penetrate said skin.

38. The interface of claim 35, wherein said first surface area is spaced outwardly from said second surface area a distance to apply a pressure to said skin sufficient to cause said skin penetrating device to penetrate said skin when said second surface area is attached to said skin.

39. The interface of claim 35, wherein said second surface area is arranged around a circumference of said bottom face.