Microdevice and method of manufacturing a microdevice

• US 20020183688A1
• Filed: 07/10/2002
• Published: 12/05/2002
• Est. Priority Date: 07/14/2000
• Status: Abandoned Application

• Current Assignee: Alexander G. Lastovich, John D. Evans, Ronald J. Pettis
• Original Assignee: Alexander G. Lastovich, John D. Evans, Ronald J. Pettis
• Inventors: Evans, John D., Pettis, Ronald J., Lastovich, Alexander G.
• Application Number:
  US10/192,474
• Publication Number:
  US 20020183688A1
• Time in Patent Office: Days
• US Class Current: 604/27
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• 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 37/0015 by using microneedles

Abstract

A device for monitoring, sampling or delivering a substance though the skin of a patient includes a support and a microdevice having at least one skin penetrating member. The support has a substantially flat bottom surface with the skin penetrating member extending beyond the bottom surface. An outlet port extends through the support to the bottom surface at a location between the skin penetrating member and the outer edge of the support for drawing a vacuum to enhance penetration of the skin. The device is produced by positioning the microdevice in a recess formed in the support and applying a bonding agent to wick into a gap formed between the microdevice and the wall of the recess.

Claims

1. A method of forming a microdevice for delivering or withdrawing a substance through the skin of a patient, comprising the steps of:

providing a support having a bottom face with a recessed area having a dimension less than a dimension of said bottom face,

positioning a skin penetrating device in said recessed area of said support, said skin penetrating device having a base and at least one skin penetrating member, said base having a dimension less than said dimension of said recessed area, and

applying a bonding amount of a bonding agent to at least one location between said support and said base in said recessed area, said bonding agent having a viscosity to wick between said base and said support.

2. The method of claim 1, wherein said base is a silicon wafer and said skin penetrating member is a microneedle array.

3. The method of claim 1, wherein said base has a thickness of about 250 microns.

4. The method of claim 1, wherein said recessed area has a depth equal to or less than a thickness of said base.

5. The method of claim 1, wherein said recessed area has a bottom surface parallel with said bottom face of said support and a side face extending between said bottom face of said support and said bottom surface of said recess, said method comprising positioning said skin penetrating device on said bottom surface.

6. The method of claim 5, wherein said side face of said recessed area is substantially perpendicular to said bottom face of said support.

7. The method of claim 5, wherein said recessed area is dimensioned to define a gap between said side face and said base of said skin penetrating member, and said method comprises applying said bonding agent to said gap.

8. The method of claim 1, wherein said support includes at least one channel communicating with said recessed area, said method comprising applying said bonding agent to said channel whereby said bonding agent flows into said recessed area.

9. The method of claim 8, wherein said at least one channel is an open channel on said bottom face of said support.

10. The method of claim 8, wherein said at least one channel has a first end connected to said recessed area and a second end connected to a reservoir formed in said support, said method comprising applying said bonding agent to said reservoir whereby said bonding agent flows through said at least one channel to said recessed area.

11. The method of claim 1, wherein said support has a cavity communicating with said recessed area.

12. The method of claim 11, wherein said support includes an opening extending from a top face to said cavity.

13. The method of claim 10, wherein said support has at least one port communicating with said bottom face, said at least one port being spaced from said recessed area.

14. The method of claim 1, wherein said base of said penetrating device is a silicon wafer and said at least one skin penetrating member is an array of microneedles.

15. The method of claim 1, wherein said skin penetrating device includes at least one passage extending through said base and being in communication with said at least one skin penetrating member.

17. The method of claim 16, wherein said bottom face of said support includes a recessed area having a dimension less than a dimension of said bottom face, and wherein said skin penetrating device includes a base fitted in said recessed area and coupled to said support.

18. The method of claim 16, wherein said support has an outer edge spaced from and surrounding said at least one skin penetrating member and an annular flange coupled to said outer edge and extending away from said support.

19. The method of claim 18, wherein said support further includes an outlet port communicating with said bottom face of said support between said annular flange and said skin penetrating member, and said method comprises applying a vacuum source to said outlet port to reduce the pressure between said support and said skin.

20. The method of claim 16, wherein said skin penetrating device includes an axial passage in communication with said central passage of said support.

21. The method of claim 16, wherein said at least one skin penetrating device comprises an array of skin penetrating members, said skin penetrating members being selected from the group consisting of microtubes, microneedles, cannulas, blades and lancets.

22. The method of claim 16, wherein said support includes a fluid coupling communicating with said central passage, said method comprising withdrawing or supplying a substance through said fluid coupling to said central passage.

23. The method of claim 19, comprising coupling a vacuum source to said outlet port and drawing a vacuum through said coupling.

25. The device of claim 24, wherein said base is a silicon wafer and said skin penetrating member is a microneedle array.

26. The device of claim 24, wherein said base has a thickness of about 250 microns.

27. The device of claim 24, wherein said recessed area has a bottom surface parallel with said bottom face of said support and a side face extending between said bottom face of said support and said bottom surface of said recess.

28. The device of claim 27, wherein said side face of said recessed area is substantially perpendicular to said bottom face of said support.

29. The device of claim 24, wherein said support includes at least one channel communicating with said recessed area for directing said bonding material into said recessed area.

30. The device of claim 29, wherein said at least one channel is an open channel on said bottom face of said support.

31. The device of claim 24, wherein said support has at least one port communicating with said bottom face of said support between an outer edge of said support and said skin penetrating device.

32. The device of claim 24, wherein said skin penetrating device includes at least one passage extending through said base and being in communication with said at least one skin penetrating member.

33. The device of claim 32, wherein said support includes a port and a central passage communicating with said skin penetrating device for delivering or withdrawing a fluid through said device.

34. The device of claim 24, wherein said support has an outer edge spaced from and surrounding said skin penetrating device and a flange extending from said outer edge away from said bottom face of said support.

35. The device of claim 34, wherein said flange is dimensioned to contact the skin of a patient and wherein said flange includes a friction enhancing member.

36. The device of claim 35, wherein said friction enhancing member is a ridge.

37. The device of claim 35, wherein said friction enhancing member is a tacky material.

38. The device of claim 34, wherein said support further comprises a port communicating with said bottom face of said support between said flange and said skin penetrating device, and an outlet coupling communicating with said port.

40. The device of claim 39, wherein said support includes a port and a central passage communicating with said skin penetrating device for delivering or withdrawing a fluid through said device.

41. The device of claim 40, further comprising a flange on said outer edge extending away from said bottom face.

42. The device of claim 41, wherein said flange is dimensioned to contact the skin of a patient and includes a friction enhancing member.

43. The device of claim 41, wherein said skin penetrating member is a microneedle array.

16. A method of withdrawing a substance or delivering a substance through the skin of a patient, said method comprising providing a support having a central passage, a bottom face, a one skin penetrating device on said bottom face, said central passage being in communication with said skin penetrating device,

positioning said support on the skin of a patient with said bottom face of said support and said at least one skin penetrating device contacting said skin,

reducing the pressure in an area between said support and said skin to draw said skin toward said skin penetrating member and to cause said skin penetrating device to penetrate said skin, and

withdrawing or delivering a substance through the skin of said patient.

24. A device for delivering or withdrawing a substance from a patient, said device comprising:

a support member having a bottom face and a recessed area having a dimension less than a dimension of said bottom face,

a skin penetrating device having a base and at least one skin penetrating member, said base being positioned within said recessed area of said support, and

a bonding material attaching said skin penetrating device to said support member and filling a space between said recessed area and said base of said skin penetrating device.

39. A device for delivering or withdrawing a substance from a patient, said device comprising:

a support member having a bottom face, an outer edge, and a recessed area having a dimension less than a dimension of said bottom face, said support having at least one passage communicating with said bottom face between said recessed area and said outer edge,

a skin penetrating device having a base and at least one skin penetrating member, said base being positioned within said recessed area and coupled to said support.

44. A method of forming a microdevice, comprising the steps of:

providing a support having a bottom face with a recessed area having a dimension less than a dimension of said bottom face and at least one channel with said recessed area,

positioning a microdevice in said recessed area of said support, said microdevice having a base with a dimension less than said dimension of said recessed area, and

applying a bonding amount of a bonding agent to said channel, said bonding agent having a viscosity to wick along said channel and between said base and said support.

45. The method of claim 44, wherein said at least one channel is an open channel on said bottom face of said support.

46. The method of claim 45, wherein said at least one channel has a first end connected to said recessed area and a second end connected to a reservoir formed in said support, said method comprising applying said bonding agent to said reservoir whereby said bonding agent flows through said at least one channel to said recessed area.